# K080833: Love Guard Male Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Tianjin Human-Care Latex Corporation
- Decided: Aug 7, 2008 after 135 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 K010371 (2001). 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)
- K010371: Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine Lubricant, Suretex, Ltd. (2001) Summary page 1.

## Indications for use
This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.

Source page: https://510kreport.com/device/K080833
Methodology: https://510kreport.com/methodology