# K971028: Worlds Best Brand Non-Lubricated, Worlds Best Brand Lubricated

- Pathway: 510(k) (Traditional)
- Applicant: Worlds-Best Gummivarefabrik A/S
- Decided: Mar 2, 1998 after 347 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The World’s Best Latex Condoms axe to completely cover the penis during sexnal intercourse for contraception and prophy- laxis, and aid to the prevention of sexually Lransmitted diseases (8TDs). If used properly, latex condoms will help to reduce the risk of tranamission of HIV intection (AIDS) and many other sexually transmitted diseases, including, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitia B, and ayphilias. This product may also combinc a latex condom and a spermicidal lubricant. The sapermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection beforc withdrawal and some semen splill outside the condom. Howaver, tha extent of decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom.

Source page: https://510kreport.com/device/K971028
Methodology: https://510kreport.com/methodology