Cleared Special

K001189 - MODIFICATION TO CONVERTORS SURGICAL GOWNS

K001189 is an FDA 510(k) clearance for MODIFICATION TO CONVERTORS 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 9-day FDA review.

K001189 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
9d
Days
Class 2
Risk

K001189 is an FDA 510(k) clearance for the MODIFICATION TO CONVERTORS 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 April 21, 2000 after a review of 9 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 - K001189

510(k) Number K001189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2000
Decision Date April 21, 2000
Days to Decision 9 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
120d faster than avg
Panel avg: 129d · This submission: 9d
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 K001189.
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp. · Sep 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · Standard Textile Co., Inc. · Jun 2001
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
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · Allegiance Healthcare Corp. · Feb 2000
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE
K994053 · Stryker Instruments · Dec 1999