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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
ANHUI ANYU LATEX PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
ANSELL HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ANSELL HEALTHCARE PRODUCTS, LLC.
  SUBSTANTIALLY EQUIVALENT 3
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
BEST PUTRA GLOVES SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
BETA HEALTHCARE PRODUCTS PVT.LTD.
  SUBSTANTIALLY EQUIVALENT 1
BETTER CARE PLASTIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BETTER CARE PLASTIC TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 12
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
  SUBSTANTIALLY EQUIVALENT 2
CAREGLOVE GLOBAL SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
CAREPLUS (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
ECO MEDI GLOVE SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
ELIMEDICAL DEVICES (FUJIAN) INC.
  SUBSTANTIALLY EQUIVALENT 1
EMERSON & CO. S.R.L.
  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 SDB. BHD.
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
HARTALEGA SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
  SUBSTANTIALLY EQUIVALENT 2
HUTCHINSON SANTE S.N.C.
  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
LUCENXIA PRESCIENCE AG
  SUBSTANTIALLY EQUIVALENT 9
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 11
MODERN HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US LLC.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 3
MOLNLYCKE HEALTH CARE USA
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE, US LLC
  SUBSTANTIALLY EQUIVALENT 4
MOLNLYCKE HEALTHCARE, US LLC
  SUBSTANTIALLY EQUIVALENT 2
MRK HEALTHCARE PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
NEW ERA MEDICARE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
PENTAVEST HOLDINGS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS GLOVES PVT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PT MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 4
PURNA BINA SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PUYANG LINSHI MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SANREA HEALTHCARE PRODUCTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
SEMPERIT INVESTMENTS ASIA PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEMPERIT TECHNISCHE PRODUKTE GESELLCHAFT M.B.H.
  SUBSTANTIALLY EQUIVALENT 1
SENTIENX SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MOTEX HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHEN WEI (USA), INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART GLOVE CORPORATION SDN.BHD
  SUBSTANTIALLY EQUIVALENT 1
SMART GLOVE CORPORATION SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
ST.MARYS RUBBERS PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERANG NUSA SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
TERANG NUSA SND BHD
  SUBSTANTIALLY EQUIVALENT 1
TG MEDICAL SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
THE EGYPTIAN COMPANY FOR MEDICAL & ELECTRONIC INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
TOP GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
WEAR SAFE (MALAYSIA) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
WRP ASIA PACIFIC SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
WRP ASIA PACIFIC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 28 28
2015 11 11
2016 15 15
2017 20 20
2018 15 15
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 36 36
Material Puncture/Hole 34 34
Adverse Event Without Identified Device or Use Problem 22 22
Material Integrity Problem 15 15
Device Contamination with Chemical or Other Material 13 13
Torn Material 11 11
Product Quality Problem 9 9
Break 8 8
Patient-Device Incompatibility 8 8
Insufficient Information 8 8
Material Fragmentation 5 5
Hole In Material 5 5
Contamination 4 4
Material Discolored 4 4
Structural Problem 4 4
Defective Device 4 4
Contamination /Decontamination Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Contaminated During Manufacture or Shipping 4 4
Device Operates Differently Than Expected 3 3
Patient Device Interaction Problem 3 3
Cross Reactivity 3 3
Delivered as Unsterile Product 3 3
Device Emits Odor 2 2
Detachment Of Device Component 2 2
Fluid/Blood Leak 2 2
Component Missing 2 2
Detachment of Device or Device Component 2 2
Device Or Device Fragments Location Unknown 2 2
Device Markings/Labelling Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Dislodged or Dislocated 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Physical Resistance/Sticking 1 1
Failure to Clean Adequately 1 1
Biocompatibility 1 1
Device Contamination With Biological Material 1 1
Device Ingredient or Reagent Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Problem with Sterilization 1 1
Sticking 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Thermal Decomposition of Device 1 1
Device Reprocessing Problem 1 1
Entrapment of Device 1 1
Fire 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 70 70
No Clinical Signs, Symptoms or Conditions 28 28
Hypersensitivity/Allergic reaction 17 17
Insufficient Information 13 13
No Information 12 12
Foreign Body In Patient 11 11
Itching Sensation 11 11
Rash 11 11
Exposure to Body Fluids 9 9
No Consequences Or Impact To Patient 8 8
Erythema 7 7
Unspecified Infection 6 6
Burning Sensation 6 6
Swelling 5 5
Irritation 5 5
No Patient Involvement 4 4
Patient Problem/Medical Problem 4 4
No Code Available 3 3
Reaction 3 3
Skin Irritation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Partial thickness (Second Degree) Burn 2 2
Device Embedded In Tissue or Plaque 2 2
Inflammation 2 2
Tachycardia 2 2
Tissue Damage 2 2
Twitching 1 1
Local Reaction 1 1
Pain 1 1
Burn(s) 1 1
Dyspnea 1 1
Anaphylactic Shock 1 1
Bacterial Infection 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Swelling/ Edema 1 1
Burn, Thermal 1 1
Caustic/Chemical Burns 1 1
Chemical Exposure 1 1
Fluid Discharge 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Nov-14-2018
2 Ansell Healthcare Products LLC II Oct-11-2023
3 Ansell Healthcare Products LLC II Mar-30-2022
4 Ansell Healthcare Products LLC II Dec-22-2016
5 Ansell Healthcare Products LLC II Dec-15-2010
6 Ansell Healthcare Products LLC II Jul-24-2009
7 Cardinal Health II Jun-18-2009
8 Cardinal Health 200, LLC II Apr-09-2022
9 Cardinal Health 200, LLC II Aug-28-2020
10 Cardinal Health 200, LLC II Dec-19-2018
11 Medline Industries Inc II Nov-21-2017
12 WRP Asia Pacific Sdn Bhd II May-30-2018
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