Last synced on 2 December 2022 at 11:04 pm

External Condom For Anal Intercourse Or Vaginal Intercourse

Page Type
Product Code
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.
Physical State
Natural rubber latex sheath
Technical Method
Barrier device that covers the penis during anal or vaginal intercourse
Target Area
Penis, vagina, anus
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5305
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRZ is linked to regulation 21CFR884.5305, which does not seem to exist yet. It may be pending at the moment.

External Condom For Anal Intercourse Or Vaginal Intercourse

Page Type
Product Code
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.
Physical State
Natural rubber latex sheath
Technical Method
Barrier device that covers the penis during anal or vaginal intercourse
Target Area
Penis, vagina, anus
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5305
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRZ is linked to regulation 21CFR884.5305, which does not seem to exist yet. It may be pending at the moment.