FLAVORED MALE LATEX CONDOM— 510(k) K011253

Name: FDA 510(k) clearance K011253
Creator: U.S. Food and Drug Administration
Published: 2001-07-20

Substantially Equivalent

Thai Nippon Rubber Industry Co., Ltd.

FDA 510(k) clearance K011253 for FLAVORED MALE LATEX CONDOM, Substantially Equivalent on 2001-07-20. Applicant: Thai Nippon Rubber Industry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Thai Nippon Rubber Industry Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2001-04-24
Decision date: 2001-07-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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K032909 — THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM2003-12-16
K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-92000-08-08
K994095 — LATEX CONDOM2000-01-18

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