Data / Medical devices / Barrier, Std, Oral Sex
Barrier, Std, Oral Sex (MSC): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Barrier, Std, Oral Sex (product code MSC, Class 2, 21 CFR 884.5300). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on July 14, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MSC
- Device class
- 2
- Regulation
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| Malaysia | 2 |
| United States | 1 |
| United Kingdom | 1 |
| Thailand | 1 |
Makers of Barrier, Std, Oral Sex
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Global Protection Corp. | Lynn, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | August 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Sanctuary Health Sdn Bhd | Chemor Perak, Malaysia | Exporter to the US, Manufacturer | 1 | March 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Four D Rubber Co Ltd | HEANOR Derbyshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innolatex (thailand) Limited | Hat Yai Songkhla, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karex Industries Sdn Bhd | PONTIAN Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.