Cleared Traditional

K000901 - KLINIDRAPE SURGICAL GOWNS

K000901 is an FDA 510(k) clearance for KLINIDRAPE SURGICAL GOWNS, manufactured by Molnlycke Health Care, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K000901 · Molnlycke Health Care, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2000
Decision
106d
Days
Class 2
Risk

K000901 is an FDA 510(k) clearance for the KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PRO.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Molnlycke Health Care, Inc. (Eddystone, US). The FDA issued a Cleared decision on July 5, 2000 after a review of 106 days - within the typical 510(k) review window.

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 Molnlycke Health Care, Inc. devices

FDA 510(k) Submission Details - K000901

510(k) Number K000901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2000
Decision Date July 05, 2000
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 166
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K000901.
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp. · Sep 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · Standard Textile Co., Inc. · Jun 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
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
K993170 · Medline Industries, Inc. · Mar 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · Allegiance Healthcare Corp. · Feb 2000