MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)— 510(k) K990669

Name: FDA 510(k) clearance K990669
Creator: U.S. Food and Drug Administration
Published: 1999-05-17

Substantially Equivalent

Dongkuk Techco Rubber Industries Sdn. Bhd.

FDA 510(k) clearance K990669 for MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9), Substantially Equivalent on 1999-05-17. Applicant: Dongkuk Techco Rubber Industries Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Dongkuk Techco Rubber Industries Sdn. Bhd.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1999-03-02
Decision date: 1999-05-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Penang, MY

Download summary PDF View on FDA.gov ↗

Recent devices under product code LTZ

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K033163 — CAUTION CONDOMS2004-04-27
K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM2002-06-12
K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM2001-04-27
K003375 — CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX2001-01-28
K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-92000-08-08

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