# K060797: NAKED

- Pathway: 510(k) (Traditional)
- Applicant: Veraxis Int'L, Inc.
- Decided: Apr 7, 2006 after 14 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. The FDA summary names its predicate without a number.
- (no number) Oceans Seven, Intn'l The Official Condom of the 21st Century (They-Fit) condoms: named in the summary without a submission number
- (no number) Church & Dwight, Trojan Magnum XL condoms: named in the summary without a submission number

## Indications for use
The Veraxis Int'l Inc. Naked Tm condom is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K060797
Methodology: https://510kreport.com/methodology