Cleared Traditional

K062899 - MICROTEK MEDICAL SURGICAL GOWN/TOGA

K062899 is the FDA 510(k) clearance for MICROTEK MEDICAL SURGICAL GOWN/TOGA by Microtek Medical, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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
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.

Device Classification

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 148
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K062899.
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · Kimberly-Clark Corp. · Aug 2009
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
K080795 · Kimberly-Clark Corp. · Sep 2008
STRYKER T6 HOODS AND TOGAS
K063005 · Stryker Instruments · Mar 2007
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
KIMBERLY-CLARK PROCEDURE GOWN
K052824 · Kimberly-Clark Corp. · May 2006
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · Medline Industries, Inc. · Mar 2005