Cleared Traditional

K060181 - COMPE1 1 -PLY SURGICAL GOWNS

K060181 is an FDA 510(k) clearance for COMPE1 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 43-day FDA review.

K060181 · Standard Textile Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
43d
Days
Class 2
Risk

K060181 is an FDA 510(k) clearance for the COMPE1 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 March 7, 2006 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K060181

510(k) Number K060181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2006
Decision Date March 07, 2006
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 K060181.
MICROTEK MEDICAL SURGICAL GOWN/TOGA
K062899 · Microtek Medical, Inc. · Jan 2007
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
KIMBERLY-CLARK PROCEDURE GOWN
K052824 · Kimberly-Clark Corp. · May 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