Barrier, Std, Oral Sex
A Standard Oral Sex Barrier is a physical barrier device intended for use during oral sexual activity to reduce the risk of sexually transmitted infections by preventing direct mucosal contact. It is classified as FDA Class 2, requiring 510(k) premarket clearance to demonstrate substantial equivalence to a legally marketed predicate device. The product code is MSC, regulated under 21 CFR 884.5300, and reviewed by the Obstetrics/Gynecology panel. The device is not an implant and does not carry a life-sustaining designation.
Research product code MSC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MSC
- Device Class
- FDA class 2
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212928 | Lorals | Apr 22, 2022 | Substantially Equivalent | Brazen Goods Inc. Dba Lorals |
| K212037 | SancDam Latex Oral Dam | Mar 28, 2022 | Substantially Equivalent | Sanctuary Health Sdn. Bhd. |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Aug 05, 2021 | Substantially Equivalent | Pamco Distributing, Inc. |
| K091769 | TRUST DAM | Feb 05, 2010 | Substantially Equivalent | Line One Laboratories, Inc. |
| K990067 | SHEER GLYDE DAMS | Feb 19, 1999 | Substantially Equivalent | Louise C. Myers |
| K970577 | GLYDE DAM LOLLYES | Jan 08, 1998 | Substantially Equivalent | Glyde USA, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.