FDA product code OBY

Condom, Female, Animal Tissue

Obstetrics/Gynecology·Class 3·21 CFR 884.5330
US regulatory classifications
US Product Code (FDA)
OBY
View Product Code Classification →
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 884.5330
View CFR Regulation →
Medical specialty
Obstetrics/Gynecology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.

Search keywords
About this record

Condom, Female, Animal Tissue is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.