Cleared Traditional

COVER GOWN (K952116) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952116 · American Threshold Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
123d
Days
Class 2
Risk

K952116 is an FDA 510(k) clearance for the COVER 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 5, 1995 after a review of 123 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 K952116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1995
Decision Date September 05, 1995
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
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 67
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K952116.
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
K232849 · Owens & Minor (O&M) Halyard, Inc. · May 2024
Copioumed Chemotherapy Isolation Gown
K230135 · Copioumed International, Inc. · Oct 2023
Disposable Isolation Gown
K223467 · Nanning Tecbod Biological Technology Co., Ltd. · Feb 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223304 · Xiamen Probtain Medical Technology Co., Ltd. · Feb 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223411 · Xiamen Probtain Medical Techology Co., Ltd. · Jan 2023
Paneffort AAMI Level 3 Isolation Gown
K212717 · Paneffort, LLC · Nov 2022