# K983320: Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors

- Pathway: 510(k) (Traditional)
- Applicant: Suretex Prophylactics (India), Ltd.
- Decided: Dec 11, 1998 after 81 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 K932982 (1994). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K030176: Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing Lubricant (2003), 1 descendant of its own
- K033541: Long Love Condom (2003), 0 descendants of its own
- K992081: Various Ansell Tradenames or Private Label (1999), 0 descendants of its own

## Recalls of this device
- Nov 5, 2012 · Class II · Z-0717-2013: One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.

## 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/K983320
Methodology: https://510kreport.com/methodology