Cleared Traditional

K041653 - COMPEL 1-PLY SURGICAL GOWNS

Also marketed or referenced as:
COMPEL ISOLATION GOWNS

K041653 is an FDA 510(k) clearance for COMPEL 1-PLY SURGICAL GOWNS, 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 379-day FDA review.

K041653 · Standard Textile Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
379d
Days
Class 2
Risk

K041653 is an FDA 510(k) clearance for the COMPEL 1-PLY 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 July 1, 2005 after a review of 379 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 - K041653

510(k) Number K041653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2004
Decision Date July 01, 2005
Days to Decision 379 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
250d slower than avg
Panel avg: 129d · This submission: 379d
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 K041653.
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
KIMBERLY-CLARK PROCEDURE GOWN
K052824 · Kimberly-Clark Corp. · May 2006
COMPE1 1 -PLY SURGICAL GOWNS
K060181 · Standard Textile Co., Inc. · Mar 2006
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