# K220355: Astroglide Ultra Gentle Gel

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: May 26, 2022 after 107 days
- Product code: NUC (Lubricant, Personal)
- 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: 3 generations back to K810310 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072647: Glycerin & Paraben Free Astroglide, Biofilm, Inc. (2008) Summary page 4.

## Indications for use
Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K220355
Methodology: https://510kreport.com/methodology