Cleared Traditional

PRIMAGARD SURGICAL GOWNS (K023117) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023117 · Primeline Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
58d
Days
Class 2
Risk

K023117 is an FDA 510(k) clearance for the PRIMAGARD SURGICAL GOWNS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Primeline Medical Products, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on November 8, 2002 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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

Submission Details

510(k) Number K023117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date November 08, 2002
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 23
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K023117.
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997