TPLC - Total Product Life Cycle

• Device: polymer patient examination glove
• Regulation Description: Non-powdered 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
ALCATRON GLOVES FACTORY
	SUBSTANTIALLY EQUIVALENT	1
AMAZING RUBBER PRODUCTS PVT, LTD.
	SUBSTANTIALLY EQUIVALENT	2
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	2
ANHUI KINDGUARD MEDICAL SUPPLIES TECHNOLOGY 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	2
ASPEN GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
AT GLOVE ENGINEERING SDN. BHD
	SUBSTANTIALLY EQUIVALENT	1
BASIC MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	6
BEIJING BIOSIS HEALING BIOLOG ICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
	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	6
BRIGHTWAY HOLDINGS SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
BYD AUTO INDUSTRY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH200, LLC
	SUBSTANTIALLY EQUIVALENT	2
CAREGLOVE GLOBAL SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	5
CAREPLUS (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
CENTRAL MEDICARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	7
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
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 INDUSTRIES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
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
DELL CORNING CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DEZHOU PURISM MEDICAL TECHNOLOGY CO., 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
ECOGLOVE MEDICAL MANUFACTURING COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EDMA GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	2
EG GROUP PRODUCT AND SERVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EMERALD GLOVE MANUFACTURING SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
ENCOMPASS INDUSTRIES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
EONS GLOVES (THAILAND) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EVER GLOBAL (VIETNAM) ENTERPRISE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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
GENABIO DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	1
GLOVE ONE, LLC
	SUBSTANTIALLY EQUIVALENT	1
GLOVMASTER SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
GMP MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
GOODGLOVES INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
GRAND WORK PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
GREAT ECO GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
GREAT HARVEST TRADING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG JIALI PHARMACEUTICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG KINGFA SCI. & TECH.CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
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
HANGZHOU RUNHENG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HARBOUR HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
HARTALEGA NGC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	5
HEBEI ASTRO MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI KANGXIDA MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HENGCHANG (DONGYING) MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HOLIK ASIA GROUP CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
HONG SENG GLOVES SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
HSK MEDICAL APPARATUS FOSHAN CHINA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUAYUAN MEDICAL TECHNOLOGY(SHANGQIU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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
INNER MONGOLIA BOMING MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INNER MONGOLIA CUREGUARD MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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 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 TIANSHUO MEDICAL 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
JIUJIANG TAIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	3
KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
KGM GLOVES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY-CLARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
KOON SENG SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
KOOVE IOT PVT. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
KOSSAN INTERNATIONAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
KOSSAN INTERNATIONAL SDN BHD3
	SUBSTANTIALLY EQUIVALENT	1
KSG MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	3
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	5
MASTERMAX PLASTIC (HUIZHOU), LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDI LEGION SDN.BHD
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDITECH GLOVES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
MEGINE INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
MERCATOR MEDICAL (THAILAND), LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEXPO INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEZORRISON MEDICAL TECHNOLOGY (DONGYING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOTEX HEALTHCARE (ANHUI) CO., LTD.
	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
NB MEDICAL COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEPHRON NITRILE, LLC
	SUBSTANTIALLY EQUIVALENT	3
NEPHRON PHARMACEUTICALS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NEW ERA MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
NINGXIA QIAOEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIUJIAN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
NOVID PPE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
NTL INNOVATION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
O&M HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	11
ONE GLOVE INDUSTRIAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
ONETEXX SDN BHD
	SUBSTANTIALLY EQUIVALENT	7
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
PROFESSIONAL LATEX SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
PROGRAM INSITE, LLC
	SUBSTANTIALLY EQUIVALENT	1
PROTECT GLOVES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PT. MAJA AGUNG LATEXINDO
	SUBSTANTIALLY EQUIVALENT	1
PT. SHAMROCK MANUFACTURING CORPORA
	SUBSTANTIALLY EQUIVALENT	1
PT. SINTONG UNIGOLDEN GLOVE
	SUBSTANTIALLY EQUIVALENT	1
PT. UNIVERSAL GLOVES
	SUBSTANTIALLY EQUIVALENT	1
RAXWELL INDUSTRIAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
REAL STAR MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RHINO HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	3
RIMBA GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RIMBA GLOVE SND BHD
	SUBSTANTIALLY EQUIVALENT	1
RIVERSTONE RESOURCES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
RMKH GLOVE (CAMBODIA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RUBBEREX ALLIANCE PRODUCTS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RUBBEREX ALLIANCE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
S&S GLOVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
SAFESKIN RETAILING (HK) LIMITED
	SUBSTANTIALLY EQUIVALENT	4
SAFESOURCE DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	2
SEMPERIT INVESTMENTS ASIA PTE , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG BLUE SAIL HEALTH TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG DS SAFETY TECHNOLOGY 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 MAIDA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG SHANGWEI MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG XINGYU GLOVES 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	11
SHENZHEN SHIQIAO SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHOWA BEST GLOVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIAM NTD CORPORATION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIYANG JAYSUN MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIYANG THREEGUARD MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SMART GLOVE CORPORATION SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
SRI TRANG GLOVES THAILAND (PUBLIC COMPANY LIMITED)
	SUBSTANTIALLY EQUIVALENT	1
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
SUNRAY MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUQIAN LINGLIAN MEDICAL TECHNOLOGY 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 LANHAI MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TEC GLOVES INDUSTRY (M) SDN.BHD.
	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 GLOVE MEDICAL (THAILAND) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UG GLOBAL RESOURCES 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
VIETGLOVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VIP GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
VISTA INDUSTRIES,, LLC
	SUBSTANTIALLY EQUIVALENT	1
W.A. RUBBERMATE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WATCHTOWER PPE SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WRP ASIA PACIFIC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
WUHAN HUIRUI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XINGYU MEDICAL TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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
YTY INDUSTRY (MANJUNG) SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
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
ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZIBO BLUE SAIL HEALTH TECHNOLOGY 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 SHENGKUN CHEMICAL INDUSTRY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	20	20
2022	19	31
2023	24	24
2024	76	76
2025	73	73
2026	135	135

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	134	134
Material Puncture/Hole	35	35
Contamination	19	19
Defective Device	16	16
Patient-Device Incompatibility	15	27
Product Quality Problem	15	15
Patient Device Interaction Problem	14	14
Physical Resistance/Sticking	13	13
Material Integrity Problem	13	13
Adverse Event Without Identified Device or Use Problem	12	12
Break	11	11
Component Missing	9	9
Component Incompatible	7	7
Inadequacy of Device Shape and/or Size	7	7
Material Discolored	7	7
Device Contaminated During Manufacture or Shipping	4	4
Device Damaged Prior to Use	4	4
Device Contamination with Chemical or Other Material	4	4
Contamination /Decontamination Problem	4	4
Tear, Rip or Hole in Device Packaging	3	3
Use of Device Problem	3	3
Biocompatibility	2	2
Melted	2	2
Appropriate Term/Code Not Available	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Insufficient Information	2	2
Output Problem	2	2
Fail-Safe Problem	1	1
Material Fragmentation	1	1
Delivered as Unsterile Product	1	1
Material Deformation	1	1
Packaging Problem	1	1
Device Emits Odor	1	1
Microbial Contamination of Device	1	1
Material Separation	1	1
Expiration Date Error	1	1
Contamination of Device Ingredient or Reagent	1	1
Protective Measures Problem	1	1
Separation Failure	1	1
Device Markings/Labelling Problem	1	1
Fungus in Device Environment	1	1
Improper or Incorrect Procedure or Method	1	1
Chemical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	208	208
Insufficient Information	45	45
Hypersensitivity/Allergic reaction	29	29
Skin Inflammation/ Irritation	29	29
Rash	26	29
Erythema	10	19
Contact Dermatitis	7	7
Itching Sensation	6	6
Inflammation	5	5
Swelling/ Edema	5	5
Burning Sensation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Burn(s)	3	3
Exposure to Body Fluids	3	3
Pain	3	3
Bruise/Contusion	3	3
Local Reaction	2	2
Discomfort	2	2
Fluid Discharge	2	2
Caustic/Chemical Burns	2	2
Hemorrhage/Bleeding	2	2
Eczema	2	2
Nausea	1	1
Anaphylactoid	1	1
Blister	1	1
Foreign Body In Patient	1	1
Twitching	1	1
Dyspnea	1	1
Laceration(s)	1	1
Anaphylactic Shock	1	1
Anxiety	1	1
Skin Tears	1	1
Cancer	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	HUBO INTERNATIONAL INC	II	Apr-09-2021