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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device condom, synthetic
Regulation Description Condom.
Product CodeMOL
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 2
MAYER LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
OKAMOTO USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US), LLC
  SUBSTANTIALLY EQUIVALENT 1
SURETEX LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 2 2
2023 2 2
2024 2 2
2025 4 4
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 1 1
Break 1 1
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fungal Infection 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Itching Sensation 3 3
Swelling/ Edema 3 3
Scar Tissue 2 2
Urinary Tract Infection 2 2
Muscle Weakness/Atrophy 1 1
Hypersensitivity/Allergic reaction 1 1
Emotional Changes 1 1
Purulent Discharge 1 1
Localized Skin Lesion 1 1
Burning Sensation 1 1
Erythema 1 1
Discomfort 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1
Abortion 1 1
Distress 1 1
Facial Paralysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
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