# K250142: Water-based Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Global Protection Corp.
- Decided: Aug 8, 2025 after 203 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Water-based lubricant is intended for penile, vaginal and/or anal application to moisturize and lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubricant. 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/K250142
Methodology: https://510kreport.com/methodology