Cleared Traditional

K982369 - CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS

K982369 is an FDA 510(k) clearance for CONVERTORS, manufactured by Allegiance Healthcare Corp.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K982369 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
48d
Days
Class 2
Risk

K982369 is an FDA 510(k) clearance for the CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on August 24, 1998 after a review of 48 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K982369

510(k) Number K982369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1998
Decision Date August 24, 1998
Days to Decision 48 days
Submission Type Traditional
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
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 48
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K982369.
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
K160361 · Primed Medical Products, Inc. · Nov 2016
Cardinal Health Isolation Gown
K160339 · Cardinal Health200, LLC · Jul 2016
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749 · Banta Healthcare · Feb 2001
KENTRON'S ISOLATION GOWN
K971917 · Kentron Health Care, Inc. · Sep 1997
IMPERVIOUS ISOLATION GOWN
K972410 · Kentron Health Care, Inc. · Sep 1997
FAR-EAST BARRIER GOWNS
K971702 · Far East Science & Technology Development Co., Ltd. · Jul 1997