# K990067: Sheer Glyde Dams

- Pathway: 510(k) (Traditional)
- Applicant: Louise C. Myers
- Decided: Feb 19, 1999 after 42 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K990042: Silon Dual-Dress, Bio Med Sciences, Inc. (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K091769: Trust Dam (2010), 4 descendants of its own
- K212928: Lorals (2022), 1 descendant of its own
- K253662: Lixi (LXOSFM1) (2026), 0 descendants of its own
- K212037: SancDam Latex Oral Dam (2022), 0 descendants of its own
- K203727: Harmony Latex Dam, Harmony Non-Latex Dam (2021), 0 descendants of its own

## Indications for use
Sheer Glyde Dams™ are a thin 10" x 6” natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) or anilingus (oral/anal sex [rimming]). Sheer Glyde Dams™, when properly used, may help reduce the risk of catching or spreading many Sexually Transmitted Diseases (“STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes, and AIDS; however, they cannot eliminate the risk. During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Sheer Glyde Dams™ should be applied each and every time before any such contact occurs. WARNING: DO NOT USE DURING PENETRATING PENILE/VAGINAL OR PENILE/ANAL INTERCOURSE. WARNING: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS. IF YOU EXPERIENCE A REACTION, STOP USING THIS PRODUCT AND CONTACT YOUR PHYSICIAN.

Source page: https://510kreport.com/device/K990067
Methodology: https://510kreport.com/methodology