Cleared Traditional

K900357 - GOLD CIRCLE COIN

K900357 is an FDA 510(k) clearance for GOLD CIRCLE COIN, manufactured by Safetex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K900357 · Safetex Corp. · Obstetrics & Gynecology device
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Apr 1990
Decision
67d
Days
Class 2
Risk

K900357 is an FDA 510(k) clearance for the GOLD CIRCLE COIN. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Safetex Corp. (Colonial Heights, US). The FDA issued a Cleared decision on April 2, 1990 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Safetex Corp. devices

FDA 510(k) Submission Details - K900357

510(k) Number K900357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1990
Decision Date April 02, 1990
Days to Decision 67 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
93d faster than avg
Panel avg: 160d · This submission: 67d
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 K900357.
TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED
K901199 · Carter Products · Apr 1990
TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED
K901200 · Carter Products · Apr 1990
TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED
K901201 · Carter Products · Apr 1990
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
K901111 · Ansell, Inc. · Mar 1990
G.S.A. COLORED CONDOMS
K901112 · Ansell, Inc. · Mar 1990
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
K895640 · Armkel, LLC · Jan 1990