Cleared Traditional

K173847 - Disposable Ultra Reinforced Surgical Gown (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173847 · Xiantao Rayxin Medical Products Co., Ltd. · General Hospital
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Jan 2019
Decision
393d
Days
Class 2
Risk

K173847 is an FDA 510(k) clearance for the Disposable Ultra Reinforced Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Xiantao Rayxin Medical Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on January 16, 2019 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Xiantao Rayxin Medical Products Co., Ltd. devices

Submission Details

510(k) Number K173847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2017
Decision Date January 16, 2019
Days to Decision 393 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
265d slower than avg
Panel avg: 128d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K173847.
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