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U.S. Department of Health and Human Services

Product Classification

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Device condom with nonoxynol-9
Regulation Description Condom with spermicidal lubricant.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeLTZ
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 884.5310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073947.htm] 
  • Labeling for Male Condoms Made of Natural Rubber Latex - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff
Third Party Review
Accredited Persons

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