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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device medical glove, specialty
Definition A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
Product CodeLZC
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
0 & M HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
ANHUI XINYISHENG MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
BETTER CARE PLASTIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRIGHTWAY HOLDINGS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CAREPLUS (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CENTRAL MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 4
CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
COMFORT RUBBER GLOVES INDUSTRIES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
ENCOMPASS INDUSTRIES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
EVER GLOBAL (VIETNAM) ENTERPRISE CORP
  SUBSTANTIALLY EQUIVALENT 1
GMP MEDICARE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
GMP MEDICARE SDN BHD (F25)
  SUBSTANTIALLY EQUIVALENT 2
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HAINAN ASTHER MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 2
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HL RUBBER INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU NANFANG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK
  SUBSTANTIALLY EQUIVALENT 1
LATEXX MANUFACTURING SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
MAXTER GLOVE MANUFACTURING SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIUJIAN TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NORTHSTAR HEALTHCARE HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
O & M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
PERUSAHAAN GETAH ASAS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
SGMP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEN WEI (USA), INC.
  SUBSTANTIALLY EQUIVALENT 2
SHEN WEI USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SHOWA BEST GLOVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEAR SAFE (MALAYSIA) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
WRP ASIA PACIFIC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 5
YTY INDUSTRY (MANJUNG) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2016 5 5
2017 7 7
2018 6 6
2019 8 8
2020 1 1
2021 2 2
2022 2 2
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Hole In Material 11 11
Material Split, Cut or Torn 5 5
Split 3 3
Break 2 2
Device Contamination with Chemical or Other Material 2 2
Patient-Device Incompatibility 2 2
Product Quality Problem 1 1
Material Integrity Problem 1 1
Material Discolored 1 1
Degraded 1 1
Appropriate Term/Code Not Available 1 1
Contamination /Decontamination Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Physical Resistance/Sticking 1 1
Device Contaminated During Manufacture or Shipping 1 1
Component Incompatible 1 1
Protective Measures Problem 1 1
Torn Material 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Consequences Or Impact To Patient 10 10
Sore Throat 2 2
No Patient Involvement 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Superficial (First Degree) Burn 1 1
Burn(s) 1 1
Inflammation 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Skin Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ansell Healthcare Products LLC II Aug-31-2011
2 O&M HALYARD INC II Dec-01-2021
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