Cleared Abbreviated

K122717 - FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK

K122717 is an FDA 510(k) clearance for FACE MASK, manufactured by Tiger Medical Products, Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 107-day FDA review.

K122717 · Tiger Medical Products, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
107d
Days
Class 2
Risk

K122717 is an FDA 510(k) clearance for the FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tiger Medical Products, Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 21, 2012 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K122717

510(k) Number K122717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2012
Decision Date December 21, 2012
Days to Decision 107 days
Submission Type Abbreviated
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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

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 557
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K122717.
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013
GREENCROSS SURGICAL MASK
K123787 · Jingzhou Haixin Green Cross Medical Products Co.,L · Jul 2013
ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
K123115 · Acme Filter Mask, Inc. · May 2013
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
K111402 · Kimberly-Clark · Oct 2011
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
K111343 · Crosstex International, Inc. · Oct 2011
SURGICAL MASKS
K111559 · Shanghai Neo-Medical Import & Export Co., Ltd. · Sep 2011
K122717 · FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
Download PDF FDA Summary Tiger Medical Product…