# K210857: Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Huanqiu Xuebao Technology Co., Ltd.
- Decided: Sep 24, 2021 after 185 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: 9 generations back to K903910 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203257: LUBi Water Based Personal Lubricant, Boya Biotechnology Co., Ltd. (2020) Summary page 4.

## Indications for use
Personal Lubricant is a water based personal lubricant, for penile and/or vaginal 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/K210857
Methodology: https://510kreport.com/methodology