# K051273: Divas Dual Pleasure Male Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Eagle Twe, Inc.
- Decided: Aug 19, 2005 after 94 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: 2 generations back to K912901 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042957: Durex Male Latex Condom with Warming Lubricant, Ssl Americas (2005) Summary page 1.
- K021492: K-Y Brand Warming Liquid Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.
- K991374: Invigra, Indus Medicare, Ltd. (1999) Summary page 1.
- K984488: Sheer Thin, Twe Companies, Inc. (1999) Summary page 1.

## Indications for use
The Divas Dual Pleasure condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.

Source page: https://510kreport.com/device/K051273
Methodology: https://510kreport.com/methodology