Cleared Traditional

K012186 - MASTER & FRANK SURGICAL GOWNS (STERILE)

K012186 is an FDA 510(k) clearance for MASTER & FRANK SURGICAL GOWNS (STERILE), manufactured by Master & Frank Ent. Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K012186 · Master & Frank Ent. Co., Ltd. · General Hospital
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Dec 2001
Decision
148d
Days
Class 2
Risk

K012186 is an FDA 510(k) clearance for the MASTER & FRANK SURGICAL GOWNS (STERILE). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Master & Frank Ent. Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on December 7, 2001 after a review of 148 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 Master & Frank Ent. Co., Ltd. devices

FDA 510(k) Submission Details - K012186

510(k) Number K012186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date December 07, 2001
Days to Decision 148 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 129d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, 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 - FYA Gown, Surgical

All 206
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K012186.
BREATHABLE SURGICAL GOWN
K023167 · Allegiance Healthcare Corp. · Oct 2002
STRYKER T4 URETHANE HOOD
K022162 · Stryker Instruments · Aug 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · Allegiance Healthcare Corp. · Mar 2002
TRIMAX
K012268 · Standard Textile Co., Inc. · Dec 2001
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp. · Sep 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · Standard Textile Co., Inc. · Jun 2001