Cleared Special

K062969 - MEDLINE STERILE DISPOSABLE SURGICAL GOWNS

K062969 is an FDA 510(k) clearance for MEDLINE STERILE DISPOSABLE SURGICAL GOWNS, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 76-day FDA review.

K062969 · Medline Industries, Inc. · General Hospital
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Dec 2006
Decision
76d
Days
Class 2
Risk

K062969 is an FDA 510(k) clearance for the MEDLINE STERILE DISPOSABLE SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on December 14, 2006 after a review of 76 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062969

510(k) Number K062969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date December 14, 2006
Days to Decision 76 days
Submission Type Special
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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

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 296
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K062969.
JOYKEY SURGICAL GOWNS (STERILE)
K062479 · Joykey Industryial , Ltd. · Mar 2007
STRYKER T4 HYTREL TOGA
K070078 · Stryker Instruments, Instruments Div. · Feb 2007
MICROTEK MEDICAL SURGICAL GOWN/TOGA
K062899 · Microtek Medical, Inc. · Jan 2007
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
KIMBERLY-CLARK PROCEDURE GOWN
K052824 · Kimberly-Clark Corp. · May 2006
K062969 · MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
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