Cleared Special

K992514 - CONVERTORS BREATHABLE SURGICAL GOWNS

K992514 is an FDA 510(k) clearance for CONVERTORS BREATHABLE SURGICAL GOWNS, manufactured by Allegiance Healthcare Corp.. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 15-day FDA review.

K992514 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
15d
Days
Class 2
Risk

K992514 is an FDA 510(k) clearance for the CONVERTORS BREATHABLE SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 15 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

FDA 510(k) Submission Details - K992514

510(k) Number K992514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1999
Decision Date August 12, 1999
Days to Decision 15 days
Submission Type Special
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
114d faster than avg
Panel avg: 129d · This submission: 15d
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 161
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K992514.
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE
K994053 · Stryker Instruments · Dec 1999
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
K993148 · Stryker Instruments · Oct 1999
CONVERTORS SURGICAL GOWNS
K992951 · Allegiance Healthcare Corp. · Sep 1999
CONVERTORS SURGICAL GOWNS
K991034 · Allegiance Healthcare Corp. · Apr 1999
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998