# K050244: Male Natural Rubber Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Nrs Global Partners
- Decided: Apr 8, 2005 after 65 days
- Product code: HIS (Condom)
- 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: 1 generation back to K002393 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002393: Non-Spermicidal Lubricated Male Latex Condom, Innolatex Sdn. Bhd (2000) Summary page 1.

## Indications for use
The NRS Global Partners male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Source page: https://510kreport.com/device/K050244
Methodology: https://510kreport.com/methodology