# K970577: Glyde Dam Lollyes

- Pathway: 510(k) (Traditional)
- Applicant: Glyde USA, Inc.
- Decided: Jan 8, 1998 after 328 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Trojan Brand Latex Condoms: named in the summary without a submission number

## Indications for use
Glyde Dam Lollyes™ are a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) ONLY, and are not intended for use during oral/anal sex. Glyde Dam Lollyes™, 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 Glyde Dam Lollyes™ 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/K970577
Methodology: https://510kreport.com/methodology