Cleared Traditional

CONDOM (RUBBER) CONTRACEPTIVE (K893039) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.

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