510(k) · Cleared
ClearedSheer Glyde Dams
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Louise C. Myers · MSC Barrier, Std, Oral Sex
Cleared on Feb 19, 1999 after a 42-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Feb 19, 1999
- Review
- 42 days
- Class
- Class II
- Product code
- MSC
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 1 citing it directly.
- This deviceK990067 Sheer Glyde DamsLouise C. Myers · 1999
- Descendant · cites it directly · 4 of its ownK091769 Trust DamLine One Laboratories, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK212928 LoralsBrazen Goods Inc. Dba Lorals · 2022
- Descendant · 3 generations on · 0 of its ownK253662 Lixi (LXOSFM1)Luwi, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK212037 SancDam Latex Oral DamSanctuary Health Sdn. Bhd. · 2022
- Descendant · 2 generations on · 0 of its ownK203727 Harmony Latex Dam, Harmony Non-Latex DamPamco Distributing, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K091769Trust DamLine One Laboratories, Inc. · 2010 · cites it directly4descendants
- K212928LoralsBrazen Goods Inc. Dba Lorals · 2022 · 2 generations on1descendant
- K253662Lixi (LXOSFM1)Luwi, LLC · 2026 · 3 generations on0descendants
- K212037SancDam Latex Oral DamSanctuary Health Sdn. Bhd. · 2022 · 2 generations on0descendants
- K203727Harmony Latex Dam, Harmony Non-Latex DamPamco Distributing, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990067 | Sheer Glyde Dams | Louise C. Myers | 1999 | — |
| +1 | K091769 | Trust Dam | Line One Laboratories, Inc. | 2010 | — |
| +2 | K212928 | Lorals | Brazen Goods Inc. Dba Lorals | 2022 | — |
| +3 | K253662 | Lixi (LXOSFM1) | Luwi, LLC | 2026 | — |
| +2 | K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | 2022 | — |
| +2 | K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSC device
- #1 K253662 Lixi (LXOSFM1)score 12.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K990042 | FDA’s K990042 is Silon Dual-Dress Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091769 | Trust Dam | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091769 (Line One Laboratories, Inc., 2010) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MSC devicesMSC Barrier, Std, Oral Sex: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSC
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSC
Too few MSC 510(k)s in any year since 2007 to give a median.
Recalls per year · MSC
No recall names MSC since 2007.
Adverse event reports per year · MSC
No MAUDE report names MSC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (132 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990067: Sheer Glyde Dams.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990067
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026