# K972836: Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors

- Pathway: 510(k) (Traditional)
- Applicant: G. Premjee (Usa), Inc.
- Decided: Oct 22, 1997 after 83 days
- Product code: LTZ (Condom With Nonoxynol-9)
- Device class: 2
- Regulation: 21 CFR 884.5310
- 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 K932982 (1994). 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)
- K942858: Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9), Suretex, Ltd. (1995) Summary page 1.
- K932982: Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi), Sime Health, Ltd. (1994) Summary page 1.

## 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/K972836
Methodology: https://510kreport.com/methodology