# K072169: Durex Synthetic Polyisoprene Male Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Ssl Americas, Inc.
- Decided: Jun 19, 2008 after 318 days
- Product code: MOL (Condom, Synthetic)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980319 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980319: Durex Ultra Comfort, London Intl., LLC (1998) Summary page 1.
- K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove, Regent Medical Americas, LLC (2005) Summary page 1.

## Recalls of this device
- Dec 19, 2018 · Class II · Z-0994-2019: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
- Dec 19, 2018 · Class II · Z-0993-2019: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
- Aug 6, 2018 · Class II · Z-0091-2019: Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
- Jul 23, 2018 · Class II · Z-3241-2018: The products failed the filed specification of 1.0kPa for Burst Pressure.

## Indications for use
The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Source page: https://510kreport.com/device/K072169
Methodology: https://510kreport.com/methodology