KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED— 510(k) K081886

Name: FDA 510(k) clearance K081886
Creator: U.S. Food and Drug Administration
Published: 2009-02-06

Substantially Equivalent

Karex Industries Sdn. Bhd.

FDA 510(k) clearance K081886 for KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED, Substantially Equivalent on 2009-02-06. Applicant: Karex Industries Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Karex Industries Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2008-07-02
Decision date: 2009-02-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pontian Kecil, Jalan Johor, 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

More clearances from Karex Industries Sdn. Bhd.

view all

K223519 — Carex Hybrid Personal Lubricant2023-08-11
K150743 — Water Based Personal Lubricant with Flavours2015-11-12
K141059 — NATURAL RUBBER LATEX MALE CONDOMS2014-08-01
K132597 — BLACK COLOURED CONDOM2013-11-25
K113056 — ORANGE COLORED CONDOMS ORANGE SCENT2012-07-03

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