Cleared Traditional

K062899 - MICROTEK MEDICAL SURGICAL GOWN/TOGA

K062899 is an FDA 510(k) clearance for MICROTEK MEDICAL SURGICAL GOWN/TOGA, manufactured by Microtek Medical, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K062899 · Microtek Medical, Inc. · General Hospital
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Jan 2007
Decision
120d
Days
Class 2
Risk

K062899 is an FDA 510(k) clearance for the MICROTEK MEDICAL SURGICAL GOWN/TOGA. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Microtek Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 120 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 Microtek Medical, Inc. devices

FDA 510(k) Submission Details - K062899

510(k) Number K062899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2006
Decision Date January 25, 2007
Days to Decision 120 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 129d · This submission: 120d
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 224
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K062899.
STRYKER T6 HOODS AND TOGAS
K063005 · Stryker Instruments · Mar 2007
JOYKEY SURGICAL GOWNS (STERILE)
K062479 · Joykey Industryial , Ltd. · Mar 2007
STRYKER T4 HYTREL TOGA
K070078 · Stryker Instruments, Instruments Div. · Feb 2007
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
LAC-MAC INNERBLOC O.R. GOWN
K061491 · Lac Mac, Ltd. · Aug 2006
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
K061308 · Cardinal Health 200, Inc. · Jun 2006