TPLC - Total Product Life Cycle

• Device: polymer patient examination glove
• Definition: A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
• Product Code: LZA
• Regulation Number: 880.6250
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
3A GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
5R MED INSTRUMENTS (CHENGDU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
AAMEDIX GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED HEALTH PRODUCTS, LOT 60 & 61
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED MEDICAL PRODUCTS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
ALCATRON GLOVES FACTORY
	SUBSTANTIALLY EQUIVALENT	1
AMAZING RUBBER PRODUCTS PVT LTD
	SUBSTANTIALLY EQUIVALENT	2
AMERCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN NITRILE OPERATIONS LLC
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN PERFORMANCE POLYMERS, LLC
	SUBSTANTIALLY EQUIVALENT	1
AMMEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ANHUI FINE GLOVE MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI FULEWEI ELECTRONIC TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI INTCO MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI INTCO MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANHUI KINDGUARD MEDICAL SUPPLIES TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI LNTCO MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANHUI POWERGUARD TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ANHUI XINYISHENG MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI ZHONG LIAN LATEX GLOVES MANUFACTURING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ANSELL HEALTHCARE PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	6
ASCEND EAGLE, INC.
	SUBSTANTIALLY EQUIVALENT	2
ASPEN GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
ASSURGUARD SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
AT GLOVE ENGINEERING SDN. BHD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEST GLOVE, INC
	SUBSTANTIALLY EQUIVALENT	1
BESTSAFE GLOVE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BETEL CARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
BETTER CARE PLASTIC TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
BETTER CARE PLASTIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
BETTER CARE PLASTIC TECHNOLOGY CP., LTD
	SUBSTANTIALLY EQUIVALENT	2
BIOGREEN YIELDS SDN.BHD
	SUBSTANTIALLY EQUIVALENT	1
BLUE SAIL MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BLUE SAIL MEDICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
BRIGHTWAY HOLDINGS SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
BRIGHTWAY HOLDINGS SDN BHD.
	SUBSTANTIALLY EQUIVALENT	2
BRIGHTWAY HOLDINGS SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	3
BYD AUTO INDUSTRY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH 200, LLC
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	3
CAREGLOVE GLOBAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
CAREGLOVE GLOBAL SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
CAREPLUS (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
CENTRAL MEDICARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	8
CENTRAL MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	3
CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU XINGRONG MEDICAL TECHNOLOGY CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU YIHUA SANITATION MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHIENMAX VIETNAM CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHUZHOU HARMONY GLOVES MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
CLOVER GLOVE COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
COMFORT RUBBER GLOVES IND. SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
COMFORT RUBBER GLOVES INDUSTRIES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	4
CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DAINAM GLOVE JOINT STOCK COMPANY
	SUBSTANTIALLY EQUIVALENT	1
DAXWELL, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DELL CORNING CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DERMA CARE PLUS PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEZHOU PURISM MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DIPPED PRODUCTS (THAILAND) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DIPPED PRODUCTS (THAILAND) LTD
	SUBSTANTIALLY EQUIVALENT	1
DONG TAI CITY HUAYI GLOVES CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN GRINVALD TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DR.BOO COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DURAMITT SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
DYNACARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
ECO MEDI GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
ECO MEDI GLOVE SDN. BHD
	SUBSTANTIALLY EQUIVALENT	5
ECO MEDI GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	4
ECO MEDI GLOVE SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	1
ECOGLOVE MEDICAL MANUFACTURING COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EDMA GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	2
EG GROUP PRODUCT AND SERVICES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ELM TREE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
EMERALD GLOVE MANUFACTURING SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
ENCOMPASS INDUSTRIES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
ENCOMPASS MEDICAL SUPPLIES INC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EONS GLOVES (THAILAND) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
EVER GLOBAL (VIETNAM) ENTERPRISE CORP
	SUBSTANTIALLY EQUIVALENT	1
EVER GLOBAL (VIETNAM) ENTERPRISE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EVER GROWTH (VIETNAM) CO. LTD.
	SUBSTANTIALLY EQUIVALENT	3
EVER GROWTH (VIETNAM) CORPORATION LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FIRST GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
FITONE LATEX PRODUCTS CO., LTD. GUANGDONG
	SUBSTANTIALLY EQUIVALENT	2
FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
FUJIAN CHUNHUI MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FUJIAN ERCON MEDICAL MANAGEMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FUJIAN JIXIANG MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
FUJIAN YUANXIN SAFETY PROTECTION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GALLANT QUALITY SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
GIGA-DRIVE SDN, BHD
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	1
GLOVMASTER SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
GMP MEDICARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
GMP MEDICARE SDN BHD (F25)
	SUBSTANTIALLY EQUIVALENT	1
GOODGLOVES INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
GRAND WORK PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
GRAND WORK PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GREAT ECO GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
GREAT HARVEST TRADING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANG DONG KINGFA SCI. & TECH.CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG JIALI PHARMACEUTICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG KINGFA SCI. & TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GUANGDONG XINGCAN BROTHERS MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU JUNDA GLOVES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU KANGLING BIOTECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GX CORPORATION SDN BHD
	SUBSTANTIALLY EQUIVALENT	9
GX CORPORATION SDN BHD (PLANT 1)
	SUBSTANTIALLY EQUIVALENT	1
HAINING MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HAINING MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HALYARD HEALTH
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU RUNHENG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HARBOUR HEALTH LLC
	SUBSTANTIALLY EQUIVALENT	1
HARTALEGA NGC SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
HARTALEGA NGC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	16
HARTALEGA SDB. BHD.
	SUBSTANTIALLY EQUIVALENT	2
HARTALEGA SDN BHD
	SUBSTANTIALLY EQUIVALENT	12
HARTALEGA SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	9
HARTALEGA SND. BHD.
	SUBSTANTIALLY EQUIVALENT	2
HE CHUANG PLASTIC & RUBBER CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HEALTHY GLOVE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HEALTHY GLOVE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
HEBEI ASTRO MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
	SUBSTANTIALLY EQUIVALENT	2
HEBEI KANGXIDA MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HENGCHANG (DONGYING) MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HENGCHANG (DONGYING) MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HI-CARE THAI GLOVES CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
HL RUBBER INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
HOLIK ASIA GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HONG SENG GLOVES SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
HONGYE PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HSK MEDICAL APPARATUS FOSHAN CHINA CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
HUAYUAN MEDICAL TECHNOLOGY(SHANGQIU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HUIKANG GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUIZHOU ANBOSON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUMANWELL HEALTHCARE GROUP MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HYCARE INTERNATIONAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ICONIC MEDICARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
IDEAL QUALITY SDN., BHD.
	SUBSTANTIALLY EQUIVALENT	1
INDUSTRIAL CLOTHINGS (PVT) LTD
	SUBSTANTIALLY EQUIVALENT	1
INDUSTRIAL CLOTHINGS, LTD.
	SUBSTANTIALLY EQUIVALENT	4
INNER MONGOLIA BOMING MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INNER MONGOLIA CUREGUARD MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	3
INNOVATIVE GLOVES CO; LTD
	SUBSTANTIALLY EQUIVALENT	2
ISIKEL MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
IVORY GLOVES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU BYTECH MEDICAL SUPPLIES CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CHERISH MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU COMPLETE SINCERITY MEDICAL NEW MATERIALS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CUREGUARD GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
JIANGSU DIHONG INDUSTRY AND TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU DONGLING PLASTIC & RUBBER CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU DONGXIN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HEALTH-PEACE MEDICAL TECHNOLOGY CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JINKE PROTECTIVE EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JINLIAN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU MAOLIN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU SHENGLIJIE SAFETY PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU STANDARD HEALTH CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU TIANSHUO MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU U-MED RUBBER & PLASTIC PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU YANFANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI KEMEI MEDICAL APPARATUS & INSTRUMENTS GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI RONGLAI MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANHAO MEDICAL INSTRUMENTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SUREFINE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIAYUAN MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIUJIANG TAIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	3
KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
KGM GLOVES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY CLARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY-CLARK CORP.
	SUBSTANTIALLY EQUIVALENT	3
KIMBERLY-CLARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
KOON SENG SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
KOON SENG SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
KOON SENG SDN.BHD
	SUBSTANTIALLY EQUIVALENT	1
KOOVE IOT PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
KOSSAN INTERNATIONAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
KOSSAN INTERNATIONAL SDN BHD3
	SUBSTANTIALLY EQUIVALENT	1
KOSSAN INTERNATIONAL SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	9
KOSSAN LATEX INDUSTRIES(M)SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
KSG MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
LAGLOVE (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
LALAN RUBBERS (PVT) LTD
	SUBSTANTIALLY EQUIVALENT	1
LANHUO MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
LATRILE GLOVES PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
LEPING SHENGDE MEDICAL TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
LIENTEH TECHNOLOGY SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
LINGSHI HONGRUIDA HEALTH PROTECTION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LULIANG HONGRUIDA HEALTH PROTECTION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LYNCMED MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
M/S TEGAMEN SAFETY PRODUCTS PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MAH SING HEALTHCARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
MASTERMAX PLASTIC (HUIZHOU) LTD
	SUBSTANTIALLY EQUIVALENT	1
MATANG MFG. SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
MAXTER GLOVE MANUFACTURING SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
MEDI LEGION SDN.BHD
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL GLOVE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDITECH GLOVES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTIRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES INC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	8
MEDLINE, INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEGINE INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
MERCATOR MEDICAL (THAILAND) LTD
	SUBSTANTIALLY EQUIVALENT	1
MERCATOR MEDICAL (THAILAND) LTD.
	SUBSTANTIALLY EQUIVALENT	4
MEXPO INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
MEZORRISON MEDICAL TECHNOLOGY (DONGYING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MINGHAO MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOTEX HEALTHCARE (ANHUI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MULTISAFE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
NAM VIET GLOVE JOINT STOCK COMPANY
	SUBSTANTIALLY EQUIVALENT	1
NANJING UNIVERSAL MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NATHAN TRADING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NB MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NEPHRON NITRILE, LLC.
	SUBSTANTIALLY EQUIVALENT	3
NEPHRON PHARMACEUTICALS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NEW ERA MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
NITRILIST GLOVES MANUFACTURING SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
NITRITEX (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
NIUJIAN TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NIUJIAN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NORTHSTAR HEALTHCARE HOLDINGS
	SUBSTANTIALLY EQUIVALENT	6
NOVID PPE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
NTL INNOVATION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
O & M HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	5
O & M HAYLARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
O&M HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	4
ONE GLOVE INDUSTRIAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
ONETEXX SDN BHD
	SUBSTANTIALLY EQUIVALENT	7
OWENS & MINOR HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
PASTEL GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
PENTAVEST HOLDINGS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
PHU DUC HUY PRODUCTION TRADING SERVICES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PINGAN MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
PLATINUM GLOVE INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
PLATINUM GLOVE INDUSTRIES SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	1
PREVENTIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRIMUS GLOVES PVT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PROFESSIONAL LATEX SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
PROFIT POINT MANUFACTURING SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
PROTECT GLOVES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PT MAHAKARYA INTI BUANA
	SUBSTANTIALLY EQUIVALENT	1
PT. MAHAKARYA INTI BUANA
	SUBSTANTIALLY EQUIVALENT	1
PT. MAJA AGUNG LATEXINDO
	SUBSTANTIALLY EQUIVALENT	2
PT. MEDISAFE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	4
PT. SHAMROCK MANUFACTURING CORPORA
	SUBSTANTIALLY EQUIVALENT	1
PT. SINTONG UNIGOLDEN GLOVE
	SUBSTANTIALLY EQUIVALENT	1
PT. SMART GLOVE INDONESIA
	SUBSTANTIALLY EQUIVALENT	4
PT. UNIVERSAL GLOVES
	SUBSTANTIALLY EQUIVALENT	1
PUYANG LINSHI HEALTH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
QUALITY GALLANT SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
QUBE MEDICAL PRODUCT SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RAXWELL INDUSTRIAL LLC
	SUBSTANTIALLY EQUIVALENT	1
REAL STAR MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RHINO HEALTH INC
	SUBSTANTIALLY EQUIVALENT	1
RHINO HEALTH INC.
	SUBSTANTIALLY EQUIVALENT	2
RIMBA GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RIMBA GLOVE SND BHD
	SUBSTANTIALLY EQUIVALENT	1
RIVERSTONE RESOURCES SDN BHD
	SUBSTANTIALLY EQUIVALENT	6
RIVERSTONE RESOURCES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	4
RMKH GLOVE (CAMBODIA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RUBBERCARE PROTECTION PRODUCTS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RUBBEREX ALLIANCE PRODUCTS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RUBBEREX ALLIANCE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
S&S GLOVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SAFESKIN RETAILING (HK) LIMITED
	SUBSTANTIALLY EQUIVALENT	4
SAFESOURCE DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SANREA HEALTHCARE PRODUCTS PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
SEMPERIT INVESTMENTS ASIA PTE LTD.
	SUBSTANTIALLY EQUIVALENT	2
SEMPERIT INVESTMENTS ASIA PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SGMP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG BLUE SAIL HEALTH TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG DS SAFETY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HENGYA PACKAGING PRINTING CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HUIWOSHENG HEALTH TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG INTCO MEDICAL PRODUCTS CO, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG JIESHI MEDICAL PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG MAIDA MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG XINGYU GLOVES CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG XINGYU GLOVES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG XINSHI MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG YINGHNG MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANXI HONGJIN PLASTIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
SHANXI NACOSA MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHEN WEI (USA), INC.
	SUBSTANTIALLY EQUIVALENT	5
SHEN WEI USA INC.
	SUBSTANTIALLY EQUIVALENT	15
SHENZHEN SHIQIAO SCIENCE AND TECHNOLOGY CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHOWA BEST GLOVE, INC
	SUBSTANTIALLY EQUIVALENT	1
SHOWA BEST GLOVE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIAM NTD CORPORATION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIAM SEMPERMED CORP. LTD.
	SUBSTANTIALLY EQUIVALENT	5
SIAM SEMPERMED CORP., LTD
	SUBSTANTIALLY EQUIVALENT	1
SIEM AEMPEMED CORP., LTD
	SUBSTANTIALLY EQUIVALENT	1
SIYANG JAYSUN MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIYANG THREEGUARD MEDICAL SUPPLIES CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
SMART GLOVE CORP. SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
SMART GLOVE CORPORATION SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
SMART GLOVE CORPORATION SDN.BHD
	SUBSTANTIALLY EQUIVALENT	1
SMART GLOVE CORPORATION SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	1
SRI TRANG GLOVES (THAILAND) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SRI TRANG GLOVES (THAILAND) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	3
SRIRUNGRUANG GLOBAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ST FUTURE INTERNATIONAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
STAR INVESTMENT AND TRADE JOINT STOCK COMPANY
	SUBSTANTIALLY EQUIVALENT	1
STRONGHOLD GROUP LLC
	SUBSTANTIALLY EQUIVALENT	1
SUMMIT GLOVE, INC
	SUBSTANTIALLY EQUIVALENT	3
SUMMIT GLOVE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNMAX VIETNAM CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
SUQIAN LINGLIAN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SUQIAN XINGYE GLOVE CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SUQIAN XINGYE GLOVE CO,LTD
	SUBSTANTIALLY EQUIVALENT	1
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNTEX HEALTHCARE PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SYNTEX HEALTHCARE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TAISHAN WEIBANG MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIZHOU KANGJIAN MEDICAL EQUIPMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN BAOJIE GLOVE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN KAIYUE GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN LANHAI MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN XIANGRUI PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
TEC GLOVES INDUSTRY (M) SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	1
TEKMEDIC (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
TERANG NUSA SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
TG MEDICAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
THAI HUA HOLDING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THAI MEDICAL GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THAI RAYONG PRODUCT GLOVE ZOUPURE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
THAI RUBBER GLOVES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THAI RUBBER INDUSTRY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
THANH CONG PHARMACEUTICAL AND TRADING COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN AOSHANG OUTDOOR EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TK HITECH TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TOP CALIBRE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
TOP GLOVE MEDICAL (THAILAND) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TOP GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
TOP GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
TOP QUALITY GLOVE SDN. BHD
	SUBSTANTIALLY EQUIVALENT	1
UG GLOBAL RESOURCES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
UG GLOBAL RESOURCES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
UG HEALTHCARE (USA), INC.
	SUBSTANTIALLY EQUIVALENT	1
ULTRAWIN SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
UR INDUSTRY SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
US GLOVE SUPPLY
	SUBSTANTIALLY EQUIVALENT	1
US MEDICAL GLOVE COMPANY LLC
	SUBSTANTIALLY EQUIVALENT	1
USA GLOVES
	SUBSTANTIALLY EQUIVALENT	1
UWEPORT LLC.
	SUBSTANTIALLY EQUIVALENT	1
VIET GLOVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VIETGLOVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VIP GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
VRG KHAI HOAN JOINT STOCK COMPANY
	SUBSTANTIALLY EQUIVALENT	1
W.A. RUBBERMATE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WANGHUI GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WATCHTOWER PPE SUPPLIES INC.
	SUBSTANTIALLY EQUIVALENT	1
WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WORLDMED MANUFACTURING SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
WRP ASIA PACIFIC SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
WRP ASIA PACIFIC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	4
WRP RUBBER PRODUCTS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
WUHAN HUIRUI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WUHAN ZONSEN MEDICAL PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
XINGDA MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XINGYU MEDICAL TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO.,
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU SARAGUARD MEDICAL SUPPLIES CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
YINGXIANG GLOVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YONGXIN HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YTY INDUSTRY (MANJUNG) SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
YTY INDUSTRY (MANJUNG) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	6
YTY INDUSTRY (MANJUNG) SDN. BHD.,
	SUBSTANTIALLY EQUIVALENT	1
YUE KANG ANHUI MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
YUNNAN HUAZHIYUAN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHANGJIAGANG HUAYUAN PROTECTIVE EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHENJIANG HUAYANG LATEX PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHENJIANG SUHUI LATEX PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHIDA GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZIBO BLUE SAIL HEALTH TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO KAIYUE MOULD TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO LANGU NEW MATERIAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO LANHUA MEDICAL PACKAGING MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO YAHAO SUPPLIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	8	8
2015	12	12
2016	25	25
2017	4	4
2018	3	3
2019	20	20
2020	4	4
2021	20	20
2022	19	19
2023	24	24
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Torn Material	23	23
Material Split, Cut or Torn	16	16
Patient-Device Incompatibility	15	15
Adverse Event Without Identified Device or Use Problem	13	13
Material Puncture/Hole	11	11
Break	10	10
Device Contamination with Chemical or Other Material	9	9
Material Integrity Problem	6	6
Product Quality Problem	6	6
Defective Device	6	6
Device Contaminated During Manufacture or Shipping	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Contamination /Decontamination Problem	3	3
Device Markings/Labelling Problem	3	3
Component Missing	3	3
Contamination	3	3
Hole In Material	3	3
Leak/Splash	2	2
Melted	2	2
Material Discolored	2	2
Device Damaged Prior to Use	2	2
Device Operates Differently Than Expected	2	2
Packaging Problem	2	2
Insufficient Information	2	2
Physical Resistance/Sticking	2	2
Sharp Edges	1	1
Appropriate Term/Code Not Available	1	1
Moisture or Humidity Problem	1	1
Device Packaging Compromised	1	1
Contamination of Device Ingredient or Reagent	1	1
Expiration Date Error	1	1
Split	1	1
Chemical Problem	1	1
Defective Component	1	1
Fungus in Device Environment	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Fragmentation	1	1
Component Incompatible	1	1
Delivered as Unsterile Product	1	1
Device Emits Odor	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	36	36
No Clinical Signs, Symptoms or Conditions	29	29
Insufficient Information	20	20
Rash	20	20
Hypersensitivity/Allergic reaction	9	9
No Information	7	7
Exposure to Body Fluids	5	5
Erythema	5	5
Swelling	5	5
Skin Irritation	4	4
Itching Sensation	4	4
Skin Inflammation/ Irritation	4	4
Reaction	3	3
Anaphylactoid	2	2
Hemorrhage/Bleeding	2	2
Respiratory Distress	2	2
Contact Dermatitis	2	2
Injury	2	2
Patient Problem/Medical Problem	2	2
Skin Tears	2	2
Chemical Exposure	2	2
No Patient Involvement	2	2
Tissue Breakdown	1	1
Foreign Body In Patient	1	1
Skin Burning Sensation	1	1
Skin Discoloration	1	1
Vitreous Floaters	1	1
Laceration(s)	1	1
Pain	1	1
Burning Sensation	1	1
Twitching	1	1
Anxiety	1	1
Needle Stick/Puncture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health	II	Oct-16-2015
2	Cardinal Health 200, LLC	II	May-06-2019
3	HUBO INTERNATIONAL INC	II	Apr-09-2021
4	Halyard Health	II	Dec-14-2016