Cleared Traditional

K971028 - WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED

K971028 is an FDA 510(k) clearance for WORLDS BEST BRAND NON-LUBRICATED, manufactured by Worlds-Best Gummivarefabrik A/S. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K971028 · Worlds-Best Gummivarefabrik A/S · Obstetrics & Gynecology device
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Mar 1998
Decision
347d
Days
Class 2
Risk

K971028 is an FDA 510(k) clearance for the WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Worlds-Best Gummivarefabrik A/S (Viby J., DK). The FDA issued a Cleared decision on March 2, 1998 after a review of 347 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.

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FDA 510(k) Submission Details - K971028

510(k) Number K971028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1997
Decision Date March 02, 1998
Days to Decision 347 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 160d · This submission: 347d
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 96
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K971028.
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000
ANSELL CONDOMS
K984392 · Ansell, Inc. · Jul 1999
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
K974323 · Reddy Medtech Health Products , Ltd. · Feb 1998
PERSONAL LUBRICATING LIQUID
K973780 · Qualis, Inc. · Nov 1997
VERY PRIVATE INTIMATE MOISTURE
K971793 · Brandwynne Corp. · Nov 1997