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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device latex patient examination glove
Regulation Description Non-powdered 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 CodeLYY
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
AMAZING RUBBER PRODUCTS PVT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
AVECENA GLOVES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
BESTSAFE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAREPLUS (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
COMFORT RUBBER GLOVES INDUSTRIES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
FITONE LATEX PRODUCTS CO., LTD. GUANGDONG
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG KINGFA SCI. & TECH.CO., LTD.
  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
JIANGXI KEMEI MEDICAL APPARATUS & INSTRUMENTS GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
KOSSAN INTERNATIONAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
NEW ERA MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
PT. UNIVERSAL GLOVES
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG INTCO MEDICAL PRODUCTS CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHEN WEI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 3
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
WRP ASIA PACIFIC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2024 6 6
2025 1 1
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2 2
Material Split, Cut or Torn 1 1
Material Puncture/Hole 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Hypersensitivity/Allergic reaction 2 2
Skin Inflammation/ Irritation 2 2
Itching Sensation 1 1
Rash 1 1
Burning Sensation 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ansell Healthcare Products LLC II Oct-02-2020
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