# K212037: SancDam Latex Oral Dam

- Pathway: 510(k) (Traditional)
- Applicant: Sanctuary Health Sdn. Bhd.
- Decided: Mar 28, 2022 after 271 days
- Product code: MSC (Barrier, Std, Oral Sex)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990067 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091769: Trust Dam, Line One Laboratories, Inc. (2010) Summary page 4.

## Indications for use
The SancDamTM Latex Oral Dam is used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

Source page: https://510kreport.com/device/K212037
Methodology: https://510kreport.com/methodology