DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM— 510(k) K012962

Name: FDA 510(k) clearance K012962
Creator: U.S. Food and Drug Administration
Published: 2001-11-09

Substantially Equivalent

Innolatex Sdn. Bhd

FDA 510(k) clearance K012962 for DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM, Substantially Equivalent on 2001-11-09. Applicant: Innolatex Sdn. Bhd. Device class: 2.

Clearance details

Applicant: Innolatex Sdn. Bhd
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2001-09-04
Decision date: 2001-11-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shah Alam,Selangor Darul Ehsan, 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 Innolatex Sdn. Bhd

view all

K053367 — MALE NATURAL RUBBER LATEX CONDOM2006-02-21
K041837 — INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED2004-09-24
K012664 — ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT2001-11-09
K012665 — ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT2001-11-09
K012964 — 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM2001-11-09

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