TPLC - Total Product Life Cycle

• Device: latex patient examination glove
• Definition: A latex patient examination glove is a disposable device made of natural rubber latex 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: LYY
• Regulation Number: 880.6250
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
A1 GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
ALATECH HEALTHCARE, LLC.
	SUBSTANTIALLY EQUIVALENT	1
AMAZING RUBBER PRODUCTS PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI ANYU LATEX PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ASPEN GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
ASSURGUARD SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
AVECENA GLOVES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
BEST PUTRA GLOVES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
BESTSAFE GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAREGLOVE GLOBAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
CAREPLUS (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
DIPPED PRODUCTS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FITONE LATEX PRODUCTS CO., LTD. GUANGDONG
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG KINGFA SCI.&TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GX CORPORATION SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
HARTALEGA NGC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
HARTALEGA SDB. BHD.
	SUBSTANTIALLY EQUIVALENT	1
HARTALEGA SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
HARTALEGA SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HI-CARE THAI GLOVES CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICONIC MEDICARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE GLOVES CO; LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI KEMEI MEDICAL APPARATUS & INSTRUMENTS GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	2
KHAI HOAN JOINT STOCK COMPANY
	SUBSTANTIALLY EQUIVALENT	2
KOON SENG SDN.BHD
	SUBSTANTIALLY EQUIVALENT	1
KOSSAN INTERNATIONAL SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
LA GLOVE (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
LAGLOVE (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
LATEXX MANUFACTURING SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTEXX MANUFACTURING SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
MERCATOR MEDICAL (THAILAND) LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEW ERA MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
NORTHSTAR HEALTHCARE HOLDINGS
	SUBSTANTIALLY EQUIVALENT	2
NORTHSTAR HEALTHCARE HOLDINGS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
OON CORP. RESOURCES
	SUBSTANTIALLY EQUIVALENT	2
PREVENTIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROFESSIONAL LATEX SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
PT. INTAN HEVEA INDUSTRY
	SUBSTANTIALLY EQUIVALENT	1
PT. UNIVERSAL GLOVES
	SUBSTANTIALLY EQUIVALENT	2
PURNABINA SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
QUBE MEDICAL PRODUCT SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RIVERSTONE RESOURCES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
RUBBERCARE PROTECTION PRODUCTS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
SANREA HEALTHCARE PRODUCTS PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
SGMP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG INTCO MEDICAL PRODUCTS CO, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHEN WEI (USA), INC.
	SUBSTANTIALLY EQUIVALENT	1
SHEN WEI USA INC.
	SUBSTANTIALLY EQUIVALENT	1
SIAM SEMPERMED CORP. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	3
SSC SURAT THANI
	SUBSTANTIALLY EQUIVALENT	1
TEKMEDIC (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
TERANG NUSA SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
THAI HUA HOLDING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
TOP CALIBRE SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
TOTAL GLOVES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
UG GLOBAL RESOURCES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
UG HEALTHCARE (USA), INC.
	SUBSTANTIALLY EQUIVALENT	1
VIET GLOVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
WEAR SAFE (MALAYSIA) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	3
WORLDMED MANUFACTURING SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
WRP ASIA PACIFIC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	6	6
2015	5	5
2016	7	7
2017	7	7
2019	7	7
2020	1	1
2021	1	1
2024	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9	9
Patient-Device Incompatibility	7	7
Device Contamination with Chemical or Other Material	5	5
Product Quality Problem	3	3
Insufficient Information	2	2
Material Integrity Problem	2	2
Out-Of-Box Failure	2	2
Device Ingredient or Reagent Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Split, Cut or Torn	1	1
Break	1	1
Device Markings/Labelling Problem	1	1
Torn Material	1	1
Material Puncture/Hole	1	1
Defective Component	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Thermal Decomposition of Device	1	1
Device Operates Differently Than Expected	1	1
Improper Chemical Reaction	1	1
Corroded	1	1
Hole In Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	7	7
Reaction	7	7
Hypersensitivity/Allergic reaction	5	5
No Information	4	4
Swelling	4	4
Insufficient Information	4	4
Respiratory Distress	2	2
Skin Irritation	2	2
Itching Sensation	2	2
Rash	2	2
Burning Sensation	2	2
No Patient Involvement	2	2
Urticaria	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Skin Inflammation/ Irritation	1	1
Asthma	1	1
Local Reaction	1	1
Burn(s)	1	1
Exposure to Body Fluids	1	1
Diarrhea	1	1
Vomiting	1	1
Dyspnea	1	1
Anaphylactic Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Adenna Inc	II	Jan-11-2012
2	Ansell Healthcare Products LLC	II	Oct-02-2020