# K982380: SURE

- Pathway: 510(k) (Traditional)
- Applicant: Pleasure Latex Products Sdn. Bhd.
- Decided: Feb 26, 1999 after 233 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023059: Unidus Male Latex Condom (2002), 1 descendant of its own
- K070511: Richter Male Latex Condom (2008), 0 descendants of its own

## Indications for use
When used in accordance with manufacturer’s instruction, condoms are effective form of contraception. If used properly, latex condoms will help to 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.

Source page: https://510kreport.com/device/K982380
Methodology: https://510kreport.com/methodology