# K974324: Latex Condoms Colour with Spermicidal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Reddy Medtech Health Products, Ltd.
- Decided: Feb 9, 1998 after 83 days
- Product code: LTZ (Condom With Nonoxynol-9)
- Device class: 2
- Regulation: 21 CFR 884.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K993782: Simplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9) (2000), 0 descendants of its own

## Indications for use
If used properly, 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. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

Source page: https://510kreport.com/device/K974324
Methodology: https://510kreport.com/methodology