Cleared Traditional

K041540 - COMBOSAFE (EUROPE) AND PROMAX (US) SURG...

K041540 is an FDA 510(k) clearance for COMBOSAFE (EUROPE) AND PROMAX (US) SURG..., manufactured by Standard Textile Co., Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K041540 · Standard Textile Co., Inc. · General Hospital
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May 2005
Decision
331d
Days
Class 2
Risk

K041540 is an FDA 510(k) clearance for the COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 5, 2005 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K041540

510(k) Number K041540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2004
Decision Date May 05, 2005
Days to Decision 331 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 129d · This submission: 331d
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 167
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K041540.
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
COMPEL SURGICAL GOWNS
K041539 · Standard Textile Co., Inc. · Apr 2005
COMPEL MLR SURGICAL GOWNS
K041541 · Standard Textile Co., Inc. · Mar 2005
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · Medline Industries, Inc. · Mar 2005