21 CFR 884.5330 — Condom, Female, Animal Tissue
Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5330
Identification
A multiple-use female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. At the conclusion of coitus, the device can be reused. It is indicated for contraception and prophylactic (preventing the transmission of sexually transmitted infections) purposes.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OBY | Condom, Female, Animal Tissue | 3 | 0 |
