Cleared Traditional

K153496 - Disposable Surgical Face Mask

K153496 is an FDA 510(k) clearance for Disposable Surgical Face Mask, manufactured by Xiantao Rayxin Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K153496 · Xiantao Rayxin Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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Jun 2016
Decision
191d
Days
Class 2
Risk

K153496 is an FDA 510(k) clearance for the Disposable Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Xiantao Rayxin Medical Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on June 15, 2016 after a review of 191 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 Xiantao Rayxin Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K153496

510(k) Number K153496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2015
Decision Date June 15, 2016
Days to Decision 191 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
62d slower than avg
Panel avg: 129d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, 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

Beijing Believe Tech.Service Co., Ltd.
RAY WANG

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 - FXX Mask, Surgical

All 526
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K153496.
Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
K153409 · Protect U Guard, LLC · Nov 2016
Surgical Face Masks (Ear loops and Tie-on)
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Skypro, SP01 Mask
K152197 · Skypro Medical Supplies Company · Aug 2016
Communicator Surgical Facemask with Clear Window
K152561 · Prestige Ameritech , Ltd. · Jun 2016
SURGICAL FACE MASK (Ear Loops and Tie-on)
K133070 · Bh Medical Products Co., Ltd. · Jun 2015
Pasture 60S Surgical Mask
K141875 · Pasture Pharma Pte, Ltd. · May 2015