Cleared Traditional

K952114 - KOOL GARD SINGLES GOWN

K952114 is the FDA 510(k) clearance for KOOL GARD SINGLES GOWN by American Threshold Industries, Inc.. It is a Class 2 General Hospital device (product code FYC) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K952114 · American Threshold Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
143d
Days
Class 2
Risk

K952114 is an FDA 510(k) clearance for the KOOL GARD SINGLES GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by American Threshold Industries, Inc. (Enka, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 143 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Threshold Industries, Inc. devices

Submission Details

510(k) Number K952114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1995
Decision Date September 25, 1995
Days to Decision 143 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYC Gown, Isolation, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FYC Gown, Isolation, Surgical

All 33
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K952114.
SURGICAL ISOLATION GOWN
K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 2018
Medline Non-Surgical Isolation Gown-
K160471 · Medline Industries, Inc. · Jan 2017
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987
CONTROL COVER GOWN
K840229 · Kimberly-Clark Corp. · Mar 1984