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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device external condom for anal intercourse or vaginal intercourse
Definition An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only.
Product CodeQRZ
Regulation Number 884.5305
Device Class 2


Premarket Reviews
ManufacturerDecision
GLOBAL PROTECTION CORP.
  GRANTED 1

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