Cleared Traditional

K023266 - PRIMAGARD SURGICAL GOWNS

K023266 is an FDA 510(k) clearance for PRIMAGARD SURGICAL GOWNS, manufactured by Primeline Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K023266 · Primeline Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
39d
Days
Class 2
Risk

K023266 is an FDA 510(k) clearance for the PRIMAGARD SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Primeline Medical Products, Inc. (Alden, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 39 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 Primeline Medical Products, Inc. devices

FDA 510(k) Submission Details - K023266

510(k) Number K023266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date November 08, 2002
Days to Decision 39 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 129d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 179
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K023266.
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · Medline Industries, Inc. · Sep 2003
DEROYAL GOWNS, STERILE, NON-STERILE
K030364 · Deroyal Industries, Inc. · Apr 2003
DHS DISPOSABLE HOOD SYSTEM
K021992 · Biomet, Inc. · Jan 2003
BREATHABLE SURGICAL GOWN
K023167 · Allegiance Healthcare Corp. · Oct 2002
STRYKER T4 URETHANE HOOD
K022162 · Stryker Instruments · Aug 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · Allegiance Healthcare Corp. · Mar 2002