Cleared Traditional

K013846 - ULTRAGARD IMPERVIOUS REINFORCED GOWN

K013846 is an FDA 510(k) clearance for ULTRAGARD IMPERVIOUS REINFORCED GOWN, manufactured by Precept 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 183-day FDA review.

K013846 · Precept Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
183d
Days
Class 2
Risk

K013846 is an FDA 510(k) clearance for the ULTRAGARD IMPERVIOUS REINFORCED GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Precept Medical Products, Inc. (Arden, US). The FDA issued a Cleared decision on May 22, 2002 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Precept Medical Products, Inc. devices

FDA 510(k) Submission Details - K013846

510(k) Number K013846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2001
Decision Date May 22, 2002
Days to Decision 183 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
54d slower than avg
Panel avg: 129d · This submission: 183d
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 206
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K013846.
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
TRIMAX
K012268 · Standard Textile Co., Inc. · Dec 2001
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp. · Sep 2001