Cleared Traditional

K893039 - CONDOM (RUBBER) CONTRACEPTIVE

K893039 is an FDA 510(k) clearance for CONDOM (RUBBER) CONTRACEPTIVE, manufactured by Chinteik Hygiene Products Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K893039 · Chinteik Hygiene Products Co., Ltd. · Obstetrics & Gynecology device
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May 1990
Decision
375d
Days
Class 2
Risk

K893039 is an FDA 510(k) clearance for the CONDOM (RUBBER) CONTRACEPTIVE. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Chinteik Hygiene Products Co., Ltd. (Pathumthani, TH). The FDA issued a Cleared decision on May 4, 1990 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chinteik Hygiene Products Co., Ltd. devices

FDA 510(k) Submission Details - K893039

510(k) Number K893039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date May 04, 1990
Days to Decision 375 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 160d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIS Condom

All 202
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K893039.
CONDOM (RUBBER) CONTRACEPTIVE
K905279 · Aladan Corp. · Feb 1991
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · Carter Products · Jun 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · Aladan Corp. · Jun 1990
TROJANS LATEX CONDOMS (MODIFIED LABELING)
K901190 · Carter Products · Apr 1990
TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)
K901191 · Carter Products · Apr 1990
TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)
K901192 · Carter Products · Apr 1990