Cleared Traditional

K171535 - SURGICAL ISOLATION GOWN

K171535 is an FDA 510(k) clearance for SURGICAL ISOLATION GOWN, manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
266d
Days
Class 2
Risk

K171535 is an FDA 510(k) clearance for the SURGICAL ISOLATION GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Jingzhou Haixin Green Cross Medical Products Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on February 15, 2018 after a review of 266 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 Jingzhou Haixin Green Cross Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K171535

510(k) Number K171535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2017
Decision Date February 15, 2018
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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

Shanghai Sungo Management Consulting Company Limited.
Raymond Luo

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 - FYC Gown, Isolation, Surgical

All 33
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K171535.
Surgical Isolation Gown
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Medline Non-Surgical Isolation Gown-
K160471 · Medline Industries, Inc. · Jan 2017
Cardinal Health Isolation Gown
K160339 · Cardinal Health200, LLC · Jul 2016
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998