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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgeon's gloves
Definition A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Product CodeKGO
Regulation Number 878.4460
Device Class 1


Premarket Reviews
ManufacturerDecision
AMAZING RUBBER PRODUCTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS, LLC.
  SUBSTANTIALLY EQUIVALENT 3
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREGLOVE GLOBAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CAREPLUS (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
ECO MEDI GLOVE SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
EMERSON & CO. SRL
  SUBSTANTIALLY EQUIVALENT 1
FITONE LATEX PRODUCTS CO., LTD. GUANGDONG
  SUBSTANTIALLY EQUIVALENT 1
GRAND WORK PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GRAND WORK PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN HBM HEALTH PROTECTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA NGC SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA NGC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 3
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
INEO TECH 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
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
LDI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LENORA GLOVE PVT LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
MODERN HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US LLC.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE, US LLC
  SUBSTANTIALLY EQUIVALENT 3
MRK HEALTHCARE PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
NEW ERA MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
PENTAVEST HOLDINGS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PUYANG LINSHI MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEMPERIT TECHNISCHE PRODUKTE GESELLCHAFT M.B.H.
  SUBSTANTIALLY EQUIVALENT 1
SENTIENX SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
SMART GLOVE CORPORATION SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE EGYPTIAN COMPANY FOR MEDICAL & ELECTRONIC INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
WRP ASIA PACIFIC SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
WRP ASIA PACIFIC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 51 51
2020 15 15
2021 14 14
2022 10 10
2023 28 28
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 34 34
Material Puncture/Hole 32 32
Adverse Event Without Identified Device or Use Problem 12 12
Product Quality Problem 9 9
Material Integrity Problem 6 6
Patient-Device Incompatibility 5 5
Contamination /Decontamination Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Material Discolored 4 4
Structural Problem 4 4
Defective Device 3 3
Break 3 3
Contamination 3 3
Device Contaminated During Manufacture or Shipping 3 3
Patient Device Interaction Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Detachment of Device or Device Component 2 2
Delivered as Unsterile Product 2 2
Device Emits Odor 2 2
Device Reprocessing Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Markings/Labelling Problem 1 1
Physical Resistance/Sticking 1 1
Failure to Clean Adequately 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 39 39
No Clinical Signs, Symptoms or Conditions 28 28
Insufficient Information 13 13
Hypersensitivity/Allergic reaction 9 9
Foreign Body In Patient 6 6
Rash 4 4
Unspecified Infection 4 4
Irritation 4 4
Exposure to Body Fluids 4 4
Itching Sensation 3 3
No Consequences Or Impact To Patient 3 3
No Patient Involvement 3 3
Burning Sensation 2 2
Patient Problem/Medical Problem 2 2
Swelling 2 2
Erythema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 2 2
No Code Available 2 2
Toxic Anterior Segment Syndrome (TASS) 1 1
Swelling/ Edema 1 1
Device Embedded In Tissue or Plaque 1 1
Anaphylactic Shock 1 1
Bacterial Infection 1 1
Pain 1 1
Tachycardia 1 1
Caustic/Chemical Burns 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ansell Healthcare Products LLC II Oct-11-2023
2 Ansell Healthcare Products LLC II Mar-30-2022
3 Cardinal Health 200, LLC II Apr-09-2022
4 Cardinal Health 200, LLC II Aug-28-2020
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