# K020586: Good Lubrications

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: Jan 24, 2003 after 336 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K072647: Glycerin & Paraben Free Astroglide (2008), 40 descendants of its own
- K094039: Hyalo Gyn (2010), 19 descendants of its own
- K150883: HyaloGYN Vaginal Hydrating Gel (2015), 9 descendants of its own
- K141581: Astroglide Natural (2014), 7 descendants of its own
- K211998: Desnuda Reflect (2021), 6 descendants of its own

## Indications for use
Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. Good lubrications may be used with condoms.

Source page: https://510kreport.com/device/K020586
Methodology: https://510kreport.com/methodology