Cleared Traditional

MED-GUARD SURGEON'S GOWN (K992445) - FDA 510(k) Clearance

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

K992445 · Kappler USA · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
211d
Days
Class 2
Risk

K992445 is an FDA 510(k) clearance for the MED-GUARD SURGEON'S GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kappler USA (Guntersville, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 211 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 Kappler USA devices

Submission Details

510(k) Number K992445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1999
Decision Date February 18, 2000
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
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 K992445.
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
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998
PROVISION SURGICAL HELMET SYSTEM
K972832 · Depuy, Inc. · Oct 1997