• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
BESTSAFE GLOVE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAREGLOVE GLOBAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CAREPLUS (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HI-CARE THAI GLOVES CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
PROFESSIONAL LATEX SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PT. UNIVERSAL GLOVES
  SUBSTANTIALLY EQUIVALENT 2
SANREA HEALTHCARE PRODUCTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
SHEN WEI USA INC.
  SUBSTANTIALLY EQUIVALENT 1
TERANG NUSA SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
THAI RUBBER GLOVES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
THAI RUBBER INDUSTRY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
UG GLOBAL RESOURCES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
VIET GLOVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 7 7
2019 7 7
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Product Quality Problem 3 3
Patient-Device Incompatibility 2 2
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Chemical Reaction 1 1
Device Contaminated During Manufacture or Shipping 1 1
Defective Device 1 1
Thermal Decomposition of Device 1 1
Hole In Material 1 1
Material Puncture/Hole 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Information 2 2
Hypersensitivity/Allergic reaction 2 2
Rash 2 2
Reaction 2 2
No Patient Involvement 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Respiratory Distress 1 1
Burning Sensation 1 1
Insufficient Information 1 1

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