Cleared Traditional

K953251 - MERTEX-PLUS O.R./SURGEONS GOWN

K953251 is an FDA 510(k) clearance for MERTEX-PLUS O.R./SURGEONS GOWN, manufactured by Mercana Industries , Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K953251 · Mercana Industries , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
55d
Days
Class 2
Risk

K953251 is an FDA 510(k) clearance for the MERTEX-PLUS O.R./SURGEONS GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Mercana Industries , Ltd. (Richmond Hill, CA). The FDA issued a Cleared decision on September 5, 1995 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mercana Industries , Ltd. devices

FDA 510(k) Submission Details - K953251

510(k) Number K953251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1995
Decision Date September 05, 1995
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 237
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K953251.
ROBISON & SMITH SURGICAL PACKS
K955586 · Robison & Smith, Inc. · Aug 1996
OREX SURGEON'S VEST
K961083 · Thantex Specialties, Inc. · Aug 1996
EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP
K960073 · Safetec of America, Inc. · Jul 1996
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
K945371 · Standard Textile Co., Inc. · Apr 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · Standard Textile Co., Inc. · Apr 1995