Cleared Traditional

K993170 - MEDLINE BREATHABLE

K993170 is the FDA 510(k) clearance for MEDLINE BREATHABLE by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K993170 · Medline Industries, Inc. · General Hospital
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Mar 2000
Decision
162d
Days
Class 2
Risk

K993170 is an FDA 510(k) clearance for the MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Waukegan, US). The FDA issued a Cleared decision on March 2, 2000 after a review of 162 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K993170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date March 02, 2000
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
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 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K993170.
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp. · Sep 2001
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · Medline Industries, Inc. · Feb 2001
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · Allegiance Healthcare Corp. · Apr 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · Allegiance Healthcare Corp. · Feb 2000
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE
K994053 · Stryker Instruments · Dec 1999
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
K993148 · Stryker Instruments · Oct 1999