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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 269
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K100971.
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
K093835 · Bam Corp., Ltd. · Feb 2011
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
K102652 · Gri Medical & Electronic Technology Co., Ltd. · Feb 2011
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
K103406 · Kimberly-Clark Corp. · Dec 2010
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
K101593 · Exact Medical Manufacturing, Inc. · Sep 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · Kimberly-Clark Corp. · Mar 2010
LAC-MAC INNERBLOC LR SURGICAL GOWNS
K092344 · Lac Mac, Ltd. · Dec 2009
K100971 · ATEK SURGICAL GOWNS
Download PDF FDA Summary Hangzhou Atek Medical…