Cleared Traditional

K910284 - CONDOMS (RUBBER CONTRACEPTIVES)

K910284 is an FDA 510(k) clearance for CONDOMS (RUBBER CONTRACEPTIVES), manufactured by Suretex, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K910284 · Suretex, Ltd. · Obstetrics & Gynecology device
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Jun 1991
Decision
132d
Days
Class 2
Risk

K910284 is an FDA 510(k) clearance for the CONDOMS (RUBBER CONTRACEPTIVES). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Suretex, Ltd. (Avondale, US). The FDA issued a Cleared decision on June 4, 1991 after a review of 132 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K910284

510(k) Number K910284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1991
Decision Date June 04, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 161d · This submission: 132d
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 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K910284.
TROJAN (TM-TBD) CONDOM
K912901 · Carter Products · Feb 1992
CONDOMS, MOODS/SHARE & RAKSHAK
K910470 · Hindustan Latex , Ltd. · Dec 1991
PLEASURE PLUS
K902772 · Medimix Products, Inc. · Aug 1991
CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW
K910550 · Safetex Corp. · Jun 1991
CMI TENDER TOUCH VE #303TT AND 404TT
K910788 · Challenge Mfg., Inc. · May 1991
MCLAUGHLIN LAPAROSCOPIC GRASPER
K910578 · Marlo Surgical Technology · Apr 1991
K910284 · CONDOMS (RUBBER CONTRACEPTIVES)
Download PDF Suretex, Ltd.