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U.S. Department of Health and Human Services

Product Classification

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Device condom, synthetic
Regulation Description Condom.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeMOL
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Testing guidance for Male Condoms Made from New Material (Non-Latex)
Third Party Review
Accredited Persons

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