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K Number
K963322
Device Name
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
Manufacturer
CUSTOM SERVICES INTL., INC.
Date Cleared
1997-01-22

(163 days)

Product Code
LTZ
Regulation Number
884.5310
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
N/A
Predicate For
K972429
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.5310 Condom with spermicidal lubricant.

(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).