Cleared Special

K080627 - PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A

K080627 is an FDA 510(k) clearance for PROMEDICAL SURGICAL GOWNS, 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 50-day FDA review.

K080627 · Promedical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
50d
Days
Class 2
Risk

K080627 is an FDA 510(k) clearance for the PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Promedical Products Co., Ltd. (Changzhou, Jiangsu, CN). The FDA issued a Cleared decision on April 24, 2008 after a review of 50 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 - K080627

510(k) Number K080627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2008
Decision Date April 24, 2008
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K080627.
SRI PLR GOWN
K080707 · Sri/Surgical Express · Nov 2008
SRI LP GOWN
K080723 · Sri/Surgical Express, Inc. · Nov 2008
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
K080795 · Kimberly-Clark Corp. · Sep 2008
STRYKER STRI-SHIELD FLYTE TOGAS
K073017 · Stryker Instruments, Instruments Div. · Nov 2007
WELMED, INC. SURGICAL GOWNS
K070431 · Welmed, Inc. · May 2007
STRYKER T6 HOODS AND TOGAS
K063005 · Stryker Instruments · Mar 2007
K080627 · PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
Download PDF Promedical Products C…