Cleared Special

K091097 - PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501

K091097 is an FDA 510(k) clearance for PROMEDICAL SURGICAL GOWN, manufactured by Promedical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 41-day FDA review.

K091097 · Promedical Products Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2009
Decision
41d
Days
Class 2
Risk

K091097 is an FDA 510(k) clearance for the PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Promedical Products Co., Ltd. (Depew, US). The FDA issued a Cleared decision on May 27, 2009 after a review of 41 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.

FDA 510(k) Submission Details - K091097

510(k) Number K091097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2009
Decision Date May 27, 2009
Days to Decision 41 days
Submission Type Special
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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K091097.
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
K093169 · A Plus International, Inc. · Nov 2009
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · Kimberly-Clark Corp. · Aug 2009
SRI LEVEL II SURGICAL GOWN
K090383 · Sri Surgical · May 2009
SKLAR SURGICAL GOWN
K082479 · Sklar Corp. · Apr 2009
SRI PLR GOWN
K080707 · Sri/Surgical Express · Nov 2008
SRI LP GOWN
K080723 · Sri/Surgical Express, Inc. · Nov 2008
K091097 · PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
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