Cleared Traditional

K172500 - Technoweb Surgical Mask

K172500 is an FDA 510(k) clearance for Technoweb Surgical Mask, manufactured by Yts Global, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K172500 · Yts Global, Inc. · General Hospital
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Mar 2018
Decision
195d
Days
Class 2
Risk

K172500 is an FDA 510(k) clearance for the Technoweb Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Yts Global, Inc. (Springfield, US). The FDA issued a Cleared decision on March 1, 2018 after a review of 195 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 Yts Global, Inc. devices

FDA 510(k) Submission Details - K172500

510(k) Number K172500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2017
Decision Date March 01, 2018
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 Peers - FXX Mask, Surgical

All 454
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K172500.
Surgical Face Mask
K182515 · Wuhan Dymex Healthcare Co., Ltd. · May 2019
Surgical Face Mask
K182514 · Xiantao Zhibo Non-Woven Products Co., Ltd. · Jan 2019
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
K180874 · 3M Healthcare · Jul 2018
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
K173062 · V&Q Manufacturing Corporation · Jan 2018
Insta-Gard Surgical and Procedure Face Mask
K142990 · Cardinal Health200, LLC · Mar 2015
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · Cardinal Health200, LLC · Jun 2014