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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device condom
Product CodeHIS
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
ALATECH HEALTHCARE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEATHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO., INC
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 6
CHURCH & DWIGHT CO.,INC.
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT VIRGINIA CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
CUPID LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MAILER PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU DAMING UNITED RUBBER PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANKOOK LATEX GONGUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLENDER SUSTAINABLE BRANDS LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOLATEX (THAILAND) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KAREX INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
KAREX INDUSTRIES SDN BHD.
  SUBSTANTIALLY EQUIVALENT 1
LELO INC.
  SUBSTANTIALLY EQUIVALENT 2
M3 GLOBAL ENTERPRISES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAPA GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAYER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL-LATEX (DUA) SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
NULATEX SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
O-RING PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
OKAMOTO U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 4
PROFILATEX, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US) LLC
  SUBSTANTIALLY EQUIVALENT 5
SHANGHAI PERSONAGE HYGIENE PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEILA PICKERING PH.D.
  SUBSTANTIALLY EQUIVALENT 1
SURETEX LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 3
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1
THEYFIT
  SUBSTANTIALLY EQUIVALENT 2
TITAN CONDOMS LLC
  SUBSTANTIALLY EQUIVALENT 1
TTK HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 3
TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG XIANGBAN LATEX PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 16 16
2015 8 8
2016 5 5
2017 8 8
2018 11 11
2019 15 15
2020 12 12
2021 16 16
2022 18 18
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Adverse Event Without Identified Device or Use Problem 15 15
Patient-Device Incompatibility 10 10
Insufficient Information 8 8
Material Fragmentation 5 5
Material Rupture 5 5
Cross Reactivity 3 3
Device Slipped 3 3
Material Integrity Problem 3 3
Device Operates Differently Than Expected 3 3
Defective Component 2 2
Device Contamination with Chemical or Other Material 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Split, Cut or Torn 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Fell 1 1
Material Puncture/Hole 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1
Out-Of-Box Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Device Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Shelf Life Exceeded 1 1
Device Dislodged or Dislocated 1 1
Entrapment of Device 1 1
Output Problem 1 1
Difficult to Remove 1 1
Patient Device Interaction Problem 1 1
Packaging Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment of Device or Device Component 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sexually Transmitted Infection 18 18
No Known Impact Or Consequence To Patient 13 13
Hypersensitivity/Allergic reaction 12 12
Insufficient Information 11 11
Rash 8 8
Reaction 8 8
Unspecified Infection 6 6
Venereal Disease 5 5
Pregnancy 5 5
Foreign Body In Patient 5 5
Pain 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Urinary Tract Infection 4 4
Viral Infection 4 4
Herpes 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Bacterial Infection 3 3
Irritation 3 3
Anaphylactoid 3 3
Skin Discoloration 3 3
Peeling 2 2
Choking 2 2
Swelling 2 2
Erythema 2 2
Exposure to Body Fluids 2 2
Injury 2 2
Burning Sensation 2 2
Pregnancy with a Contraceptive Device 2 2
Hypoxia 2 2
Local Reaction 2 2
Itching Sensation 2 2
Aspiration/Inhalation 2 2
No Information 2 2
Abnormal Vaginal Discharge 2 2
Skin Irritation 2 2
Complaint, Ill-Defined 2 2
Abdominal Pain 2 2
Undesired Nerve Stimulation 1 1
Gangrene 1 1
Immunodeficiency 1 1
Caustic/Chemical Burns 1 1
Hemorrhage/Bleeding 1 1
Hot Flashes/Flushes 1 1
Wheal(s) 1 1
HIV, Human Immunodeficiency Virus 1 1
Airway Obstruction 1 1
Device Embedded In Tissue or Plaque 1 1
Discomfort 1 1
Cramp(s) 1 1
Pulmonary Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ansell Healthcare Products LLC II Feb-20-2013
2 Ansell Healthcare Products LLC II Jan-24-2013
3 Family Dollar Stores, Llc. II Aug-17-2022
4 Reckitt Benckiser LLC II Feb-23-2017
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