Cleared Traditional

K003755 - MEDLINE BLOCKADE OR RESISTAT SURGICAL G...

K003755 is the FDA 510(k) clearance for MEDLINE BLOCKADE OR RESISTAT SURGICAL G... by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K003755 · Medline Industries, Inc. · General Hospital
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Feb 2001
Decision
73d
Days
Class 2
Risk

K003755 is an FDA 510(k) clearance for the MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 16, 2001 after a review of 73 days - a notably fast clearance 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: 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K003755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2000
Decision Date February 16, 2001
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 K003755.
STRYKER T4 URETHANE HOOD
K022162 · Stryker Instruments · Aug 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · Allegiance Healthcare Corp. · Mar 2002
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp. · Sep 2001
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · Allegiance Healthcare Corp. · Apr 2000
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
K993170 · Medline Industries, Inc. · Mar 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · Allegiance Healthcare Corp. · Feb 2000