Cleared Traditional

K954549 - SURGICAL APPAREL

K954549 is an FDA 510(k) clearance for SURGICAL APPAREL, manufactured by Global Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K954549 · Global Healthcare, Inc. · General Hospital
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Apr 1996
Decision
199d
Days
Class 2
Risk

K954549 is an FDA 510(k) clearance for the SURGICAL APPAREL. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Global Healthcare, Inc. (Roswell, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 199 days - an extended review cycle.

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 Global Healthcare, Inc. devices

FDA 510(k) Submission Details - K954549

510(k) Number K954549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date April 18, 1996
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K954549.
FAR-EAST BARRIER GOWNS
K971702 · Far East Science & Technology Development Co., Ltd. · Jul 1997
NON-STERILE ISOLATION GOWN
K970814 · American Seal Co. · May 1997
ISOLATION GOWN
K960999 · Copioumed Intl., Inc. · Dec 1996
NIOMED BARRIER GOWNS
K954747 · Amerasia Corp. · Mar 1996
KOOL GARD SINGLES GOWN
K952114 · American Threshold Industries, Inc. · Sep 1995
BARRIER GOWN, KOOL-GARD BACKLESS GOWN
K952115 · American Threshold Industries, Inc. · Sep 1995