MSC · Barrier, Std, Oral Sex
Obstetrics/Gynecology · 21 CFR 884.5300 · Class 2
Overview
| Product Code | MSC |
|---|---|
| Device Name | Barrier, Std, Oral Sex |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Classification Rationale
(1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212928 | Lorals | Brazen Goods Inc. Dba Lorals | Apr 22, 2022 | SESE |
| K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | Mar 28, 2022 | SESE |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | Aug 5, 2021 | SESE |
| K091769 | TRUST DAM | Line One Laboratories, Inc. | Feb 5, 2010 | SESE |
| K990067 | SHEER GLYDE DAMS | Louise C. Myers | Feb 19, 1999 | SESE |
| K970577 | GLYDE DAM LOLLYES | Glyde USA, Inc. | Jan 8, 1998 | SESE |
Top Applicants
- Brazen Goods Inc. Dba Lorals — 1 clearance
- Glyde USA, Inc. — 1 clearance
- Line One Laboratories, Inc. — 1 clearance
- Louise C. Myers — 1 clearance
- Pamco Distributing, Inc. — 1 clearance
