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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
Regulation Description Non-powdered surgeon's glove.
Definition A surgeon's glove is a disposable device made of natural rubber latex 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
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS, LLC.
  SUBSTANTIALLY EQUIVALENT 2
ASPEN GLOVE SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
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, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, INC.
  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
GUILIN HBM HEALTH PROTECTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA NGC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
HARTALEGA 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 4
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
PENTAVEST HOLDINGS SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS GLOVES PVT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
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
SMART GLOVE CORPORATION SDN.BHD
  SUBSTANTIALLY EQUIVALENT 1
SMART GLOVE CORPORATION SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 1
TG MEDICAL SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
TOP GLOVE SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
WEAR SAFE (MALAYSIA) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
WRP ASIA PACIFIC SDN BHD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 20 20
2018 15 15
2019 51 51
2020 15 15
2021 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 29 29
Material Puncture/Hole 23 23
Adverse Event Without Identified Device or Use Problem 14 14
Device Contamination with Chemical or Other Material 8 8
Patient-Device Incompatibility 5 5
Material Integrity Problem 4 4
Contamination /Decontamination Problem 3 3
Material Fragmentation 3 3
Break 3 3
Material Discolored 3 3
Contamination 2 2
Hole In Material 2 2
Product Quality Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Detachment of Device or Device Component 2 2
Device Markings/Labelling Problem 2 2
Device Operates Differently Than Expected 2 2
Defective Device 2 2
Torn Material 2 2
Insufficient Information 1 1
Physical Resistance/Sticking 1 1
Failure to Clean Adequately 1 1
Packaging Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Biocompatibility 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
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1
Cross Reactivity 1 1
Entrapment of Device 1 1
Thermal Decomposition of Device 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 49 49
Hypersensitivity/Allergic reaction 11 11
Itching Sensation 9 9
Rash 8 8
No Consequences Or Impact To Patient 7 7
Erythema 7 7
Exposure to Body Fluids 6 6
No Information 6 6
Insufficient Information 6 6
Burning Sensation 5 5
Foreign Body In Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Irritation 4 4
Unspecified Infection 3 3
Swelling 3 3
No Patient Involvement 3 3
Patient Problem/Medical Problem 2 2
Device Embedded In Tissue or Plaque 2 2
No Code Available 2 2
Tachycardia 2 2
Tissue Damage 1 1
Local Reaction 1 1
Skin Irritation 1 1
Reaction 1 1
Caustic/Chemical Burns 1 1
Chemical Exposure 1 1
Burn(s) 1 1
Dyspnea 1 1
Pain 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Swelling/ Edema 1 1
Fluid Discharge 1 1
Twitching 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Nov-14-2018
2 Cardinal Health 200, LLC II Aug-28-2020
3 Cardinal Health 200, LLC II Dec-19-2018
4 Medline Industries Inc II Nov-21-2017
5 WRP Asia Pacific Sdn Bhd II May-30-2018
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