Dick's Formalwear Male Latex Condom

by Dick'S Formalwear, Inc.

510(k) K050913

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K050913↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK050913	Date4 Apr 2006Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K050913
FDA Product Code: HIS

Device Class: Class II
Regulation: 21 CFR Part 884.5300
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Dick's Formalwear Male Latex Condom is a Class II medical device classified under the product code HIS and regulation number 884.5300, categorized as a condom. It is designed to be used for contraceptive purposes and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including human immunodeficiency virus (HIV).

The device is manufactured by Dick'S Formalwear, Inc., located at 3507 W. Bethany Home Rd., Phoenix, AZ 85019, US, and was authorized through the FDA 510(k) process under k_number K050913, with a decision date of 2006-04-04. The review was conducted under the Obstetrics/Gynecology advisory committee and medical specialty, with a substantially equivalent (SESE) decision. The device is single-use, and no information regarding sterility, MRI safety, sizes, or storage is provided in the data.