LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)— 510(k) K120555

Name: FDA 510(k) clearance K120555
Creator: U.S. Food and Drug Administration
Published: 2012-11-02

Substantially Equivalent

Medical-Latex (Dua) Sdn. Bhd

FDA 510(k) clearance K120555 for LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE), Substantially Equivalent on 2012-11-02. Applicant: Medical-Latex (Dua) Sdn. Bhd. Device class: 2.

Clearance details

Applicant: Medical-Latex (Dua) Sdn. Bhd
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2012-02-23
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Senai, MY

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIS

view all

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.