# K992081: Various Ansell Tradenames or Private Label

- Pathway: 510(k) (Abbreviated)
- Applicant: Suretex Prophylactics (India), Ltd.
- Decided: Aug 19, 1999 after 59 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: 2 generations back to K932982 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983320: Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors, Suretex Prophylactics (India), Ltd. (1998) Summary page 1.
- K932983: Colored Condoms (Essentials, MI Vida, Jiffi), Sime Health, Ltd. (1994) Summary page 1.

## Indications for use
The Ansell or private label black condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.

Source page: https://510kreport.com/device/K992081
Methodology: https://510kreport.com/methodology