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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 2
ANSELL HEALTHCARE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 4
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 3
ECO MEDI GLOVE SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
EMERSON & CO. S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA NGC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
LUCENXIA PRESCIENCE AG
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE
  SUBSTANTIALLY EQUIVALENT 8
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
MODERN HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US LLC
  SUBSTANTIALLY EQUIVALENT 3
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
SANREA HEALTHCARE PRODUCTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
SEMPERIT INVESTMENTS ASIA PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
WEAR SAFE
  SUBSTANTIALLY EQUIVALENT 1
WEAR SAFE (MALAYSIA) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 15 15
2017 20 20
2018 15 15
2019 51 51
2020 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 26 26
Material Puncture/Hole 21 21
Adverse Event Without Identified Device or Use Problem 10 10
Device Contamination with Chemical or Other Material 9 9
Patient-Device Incompatibility 5 5
Torn Material 4 4
Break 4 4
Insufficient Information 4 4
Material Fragmentation 3 3
Hole In Material 3 3
Cross Reactivity 3 3
Material Discolored 3 3
Defective Device 3 3
Material Integrity Problem 3 3
Contamination /Decontamination Problem 3 3
Detachment of Device or Device Component 2 2
Device Markings/Labelling Problem 2 2
Device Operates Differently Than Expected 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Or Device Fragments Location Unknown 2 2
Product Quality Problem 2 2
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Entrapment of Device 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1
Thermal Decomposition of Device 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Cuff 1 1
Tip 1 1
Packaging Problem 1 1
Device Contamination With Biological Material 1 1
Device Ingredient or Reagent Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Biocompatibility 1 1
Physical Resistance/Sticking 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 53 53
Hypersensitivity/Allergic reaction 10 10
No Consequences Or Impact To Patient 8 8
Itching Sensation 8 8
No Information 8 8
Exposure to Body Fluids 6 6
Rash 6 6
Erythema 5 5
Foreign Body In Patient 5 5
Patient Problem/Medical Problem 4 4
Unspecified Infection 4 4
Burning Sensation 4 4
Irritation 4 4
Swelling 4 4
Skin Irritation 3 3
No Patient Involvement 3 3
No Code Available 2 2
Device Embedded In Tissue or Plaque 2 2
Tachycardia 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Fluid Discharge 1 1
Inflammation 1 1
Burn(s) 1 1
Dyspnea 1 1
Tissue Damage 1 1
Twitching 1 1
Reaction 1 1
Chemical Exposure 1 1
Pain 1 1
Local Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Nov-14-2018
2 Ansell Healthcare Products LLC II Dec-22-2016
3 Cardinal Health 200, LLC II Aug-28-2020
4 Cardinal Health 200, LLC II Dec-19-2018
5 Medline Industries Inc II Nov-21-2017
6 WRP Asia Pacific Sdn Bhd II May-30-2018
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