Cleared Special

K050786 - BARRIER SURGICAL GOWNS

K050786 is an FDA 510(k) clearance for BARRIER SURGICAL GOWNS, manufactured by Molnlycke Health Care. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 42-day FDA review.

K050786 · Molnlycke Health Care · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
42d
Days
Class 2
Risk

K050786 is an FDA 510(k) clearance for the BARRIER SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Molnlycke Health Care (Newton, US). The FDA issued a Cleared decision on May 9, 2005 after a review of 42 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Molnlycke Health Care devices

FDA 510(k) Submission Details - K050786

510(k) Number K050786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2005
Decision Date May 09, 2005
Days to Decision 42 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 K050786.
KIMBERLY-CLARK PROCEDURE GOWN
K052824 · Kimberly-Clark Corp. · May 2006
COMPE1 1 -PLY SURGICAL GOWNS
K060181 · Standard Textile Co., Inc. · Mar 2006
COMPEL 1-PLY SURGICAL GOWNS
K041653 · Standard Textile Co., Inc. · Jul 2005
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
K041540 · Standard Textile Co., Inc. · May 2005
COMPEL SURGICAL GOWNS
K041539 · Standard Textile Co., Inc. · Apr 2005
COMPEL MLR SURGICAL GOWNS
K041541 · Standard Textile Co., Inc. · Mar 2005