CONDOM (RUBBER) CONTRACEPTIVE— 510(k) K893039

Name: FDA 510(k) clearance K893039
Creator: U.S. Food and Drug Administration
Published: 1990-05-04

Substantially Equivalent

Chinteik Hygiene Products Co., Ltd.

FDA 510(k) clearance K893039 for CONDOM (RUBBER) CONTRACEPTIVE, Substantially Equivalent on 1990-05-04. Applicant: Chinteik Hygiene Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chinteik Hygiene Products Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1989-04-24
Decision date: 1990-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pathumthani, TH

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIS

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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

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