Cleared Traditional

K100971 - ATEK SURGICAL GOWNS

K100971 is an FDA 510(k) clearance for ATEK SURGICAL GOWNS, manufactured by Hangzhou Atek Medical & Textile Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K100971 · Hangzhou Atek Medical & Textile Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
172d
Days
Class 2
Risk

K100971 is an FDA 510(k) clearance for the ATEK SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Hangzhou Atek Medical & Textile Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on September 27, 2010 after a review of 172 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Hangzhou Atek Medical & Textile Co., Ltd. devices

FDA 510(k) Submission Details - K100971

510(k) Number K100971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2010
Decision Date September 27, 2010
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 129d · This submission: 172d
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 179
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K100971.
TOTALSHIELD SURGICAL HELMET SYSTEM
K132386 · Zimmer, Inc. · Dec 2013
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
K102971 · Microtek Medical, Inc. · Feb 2011
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
K103406 · Kimberly-Clark Corp. · Dec 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · Kimberly-Clark Corp. · Mar 2010
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · Kimberly-Clark Corp. · Aug 2009
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
K080795 · Kimberly-Clark Corp. · Sep 2008