Cleared Traditional

K960552 - KNIGHT LIGHT NONLUBRICATED CONDOM

K960552 is an FDA 510(k) clearance for KNIGHT LIGHT NONLUBRICATED CONDOM, manufactured by Global Protection Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 651-day FDA review.

K960552 · Global Protection Corp. · Obstetrics & Gynecology device
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Nov 1997
Decision
651d
Days
Class 2
Risk

K960552 is an FDA 510(k) clearance for the KNIGHT LIGHT NONLUBRICATED CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Global Protection Corp. (Princeton, US). The FDA issued a Cleared decision on November 20, 1997 after a review of 651 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Global Protection Corp. devices

FDA 510(k) Submission Details - K960552

510(k) Number K960552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1996
Decision Date November 20, 1997
Days to Decision 651 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
490d slower than avg
Panel avg: 161d · This submission: 651d
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 239
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K960552.
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
CLINIJEL
K970581 · Hospicon Products · Sep 1997
ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
K971132 · G. Premjee (Usa), Inc. · Sep 1997
EXTRAWEAR, GENTLEMEN'S CHOICE
K972428 · Custom Services Intl., Inc. · Aug 1997