Cleared Traditional

K172987 - Surgical gown (AE1001

Also marketed or referenced as:
Surgical Gown (AG1001, AG2001, AG3001)

K172987 is an FDA 510(k) clearance for Surgical gown (AE1001, manufactured by Gmax Industries, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K172987 · Gmax Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
289d
Days
Class 2
Risk

K172987 is an FDA 510(k) clearance for the Surgical gown (AE1001, AE2001, AE3001). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Gmax Industries, Inc. (Hauppauge, US). The FDA issued a Cleared decision on July 13, 2018 after a review of 289 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 Gmax Industries, Inc. devices

FDA 510(k) Submission Details - K172987

510(k) Number K172987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date July 13, 2018
Days to Decision 289 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
160d slower than avg
Panel avg: 129d · This submission: 289d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

All 167
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K172987.
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
K190950 · Medline Industries, Inc. · Jul 2019
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
K182172 · Medline Industries, Inc. · Apr 2019
Disposable Ultra Reinforced Surgical Gown
K173847 · Xiantao Rayxin Medical Products Co., Ltd. · Jan 2019
Medline Prevention CoolZone Gown
K172954 · Medline Industries, Inc. · Jun 2018
Cardinal Health Non-Reinforced Surgical Gown
K170762 · Cardinal Health200, LLC · Jun 2017
Blockade Surgical Gown
K150598 · Medline Industries, Inc. · Apr 2016