Cleared Special

BREATHABLE IMPERVIOUS GOWNS (K012984) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012984 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
18d
Days
Class 2
Risk

K012984 is an FDA 510(k) clearance for the BREATHABLE IMPERVIOUS GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on September 24, 2001 after a review of 18 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.

View all Allegiance Healthcare Corp. devices

Submission Details

510(k) Number K012984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date September 24, 2001
Days to Decision 18 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 106
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K012984.
STRYKER T4 HYTREL ZIPPER TOGA
K040764 · Stryker Corp. · Apr 2004
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · Medline Industries, Inc. · Sep 2003
DHS DISPOSABLE HOOD SYSTEM
K021992 · Biomet, Inc. · Jan 2003
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · Medline Industries, Inc. · Feb 2001
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
K993170 · Medline Industries, Inc. · Mar 2000
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998