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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device patient examination glove, specialty
Regulation Description Non-powdered patient examination glove.
Definition A disposable latex examination glove is a device made of natural rubber latex or synthetic rubber 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 provide a barrier against potentially infectious materials and other contaminan. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
Product CodeLZC
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
0 & M HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
BRIGHTWAY HOLDINGS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CAREPLUS (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CENTRAL MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 4
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 1
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU NANFANG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
MAXTER GLOVE MANUFACTURING SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
O & M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHEN WEI USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SHOWA BEST GLOVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
YTY INDUSTRY (MANJUNG) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 7 7
2018 6 6
2019 8 8
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Hole In Material 8 8
Material Split, Cut or Torn 5 5
Patient-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Break 1 1
Degraded 1 1
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 7 7
No Patient Involvement 2 2
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Insufficient Information 1 1
Burn(s) 1 1
Inflammation 1 1
Respiratory Distress 1 1
Skin Irritation 1 1

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