# K971132: Royale Brand Latex Condoms (Silicone)-Colored/Assorted Colors

- Pathway: 510(k) (Traditional)
- Applicant: G. Premjee (Usa), Inc.
- Decided: Sep 3, 1997 after 160 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910284 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910284: Condoms (Rubber Contraceptives), Suretex, Ltd. (1991) Summary page 1.
- K932983: Colored Condoms (Essentials, MI Vida, Jiffi), Sime Health, Ltd. (1994) Summary page 1.

## Recalls of this device
- Nov 25, 2002 · Not classified · Z-0402-03: The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards

## Indications for use
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease).

Source page: https://510kreport.com/device/K971132
Methodology: https://510kreport.com/methodology