# K993779: Simplex Condoms, Latex Condoms-Flavored and Lubricated

- Pathway: 510(k) (Abbreviated)
- Applicant: P.T. Vonix Latexindo Condom (Rubber) Mfg.
- Decided: Feb 2, 2000 after 86 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: 1 generation back to K991892 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991892: Trustex Mint Flavored Condom in Green Color, Impulse Mint Flavored Condom in Green Color, Line One Laboratories (1999) Summary page 1.

## Indications for use
The Simplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics 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/K993779
Methodology: https://510kreport.com/methodology