PREVENTETTE (CONDOM)— 510(k) K872619

Substantially Equivalent

Reb Enterprises, Inc.

FDA 510(k) clearance K872619 for PREVENTETTE (CONDOM), Substantially Equivalent on 1987-11-04. Applicant: Reb Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Reb Enterprises, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1987-07-06
Decision date: 1987-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jonesville, LA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIS

K252622 — Male Latex Condom HA2026-05-04
K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom2025-11-18
K250034 — Natural rubber latex male condom2025-07-11
K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom2025-03-07
K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)2025-02-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.