Cleared Traditional

K952241 - PROTOUCH OVERGLOVE

K952241 is an FDA 510(k) clearance for PROTOUCH OVERGLOVE, manufactured by Cottrell, Ltd.. The device is a Class 2 General Hospital device with product code MMP cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K952241 · Cottrell, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
87d
Days
Class 2
Risk

K952241 is an FDA 510(k) clearance for the PROTOUCH OVERGLOVE. Classified as Cover, Barrier, Protective (product code MMP), Class II - Special Controls.

Submitted by Cottrell, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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.

FDA 510(k) Submission Details - K952241

510(k) Number K952241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1995
Decision Date August 07, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMP Device Classification - Class 2, Special Controls

Product Code MMP Cover, Barrier, Protective
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 General Hospital devices follow this clearance model.

Regulatory Peers - MMP Cover, Barrier, Protective

All 13
Devices cleared under the same product code (MMP) and FDA review panel - the closest regulatory comparables to K952241.
ULTRASOUND SYSTEMS DRAPE
K970885 · Protek Medical Products, Inc. · Sep 1997
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
K962288 · Pinnacle Products, Inc. · Jan 1997
EQUIPMENT COVERS
K961699 · United States Surgical, A Division of Tyco Healthc · Aug 1996
STERILE EQUIPMENT COVERS
K931417 · Custom Medical Products, Ltd. · Jul 1995
SURGICAL MICROSCOPE DRAPE
K944198 · Hydro-Med Products, Inc. · Nov 1994
STERILE BARRIER SLEEVE AND COVER
K930552 · Patient Safety Products, Inc. · Jul 1994
K952241 · PROTOUCH OVERGLOVE
Download PDF FDA Summary Cottrell, Ltd.