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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
CENTRAL MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
ENCOMPASS INDUSTRIES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
EVER GLOBAL (VIETNAM) ENTERPRISE CORP
  SUBSTANTIALLY EQUIVALENT 1
GMP MEDICARE SDN BHD (F25)
  SUBSTANTIALLY EQUIVALENT 1
HAINAN ASTHER MEDICAL EQUIPMENT 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
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIUJIAN TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
O & M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHOWA BEST GLOVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
YTY INDUSTRY (MANJUNG) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
Material Split, Cut or Torn 5 5
Patient-Device Incompatibility 2 2
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contaminated During Manufacture or Shipping 1 1
Appropriate Term/Code Not Available 1 1
Break 1 1
Component Incompatible 1 1
Degraded 1 1
Material Discolored 1 1
Material Rupture 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
Swelling/ Edema 2 2
Insufficient Information 2 2
Sore Throat 2 2
Superficial (First Degree) Burn 1 1
Inflammation 1 1
Local Reaction 1 1
Skin Irritation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 O&M HALYARD INC II Dec-01-2021
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