SPERMICIDAL LUBRICATED MALE LATEX CONDOM— 510(k) K010178

Name: FDA 510(k) clearance K010178
Creator: U.S. Food and Drug Administration
Published: 2001-04-27

Substantially Equivalent

Innolatex Sdn. Bhd

FDA 510(k) clearance K010178 for SPERMICIDAL LUBRICATED MALE LATEX CONDOM, Substantially Equivalent on 2001-04-27. Applicant: Innolatex Sdn. Bhd. Device class: 2.

Clearance details

Applicant: Innolatex Sdn. Bhd
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 2001-01-19
Decision date: 2001-04-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shah Alam, Selangor D.E., MY

Download summary PDF View on FDA.gov ↗

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K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-92000-08-08
K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM2000-06-08

More clearances from Innolatex Sdn. Bhd

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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
K012962 — DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM2001-11-09

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