Cleared Traditional

ULTRAGARD IMPERVIOUS REINFORCED GOWN (K013846) - FDA 510(k) Clearance

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

K013846 · Precept Medical Products, Inc. · General Hospital
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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

Submission Details

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.

Device Classification

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 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K013846.
MEDLINE SURGICAL GOWNS
K043585 · Medline Industries, Inc. · Mar 2005
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · Medline Industries, Inc. · Sep 2003
DHS DISPOSABLE HOOD SYSTEM
K021992 · Biomet, Inc. · Jan 2003
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
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998