Cleared Abbreviated

K102713 - TIGER FLAT SURGICAL MASK

K102713 is an FDA 510(k) clearance for TIGER FLAT SURGICAL 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 127-day FDA review.

K102713 · Tiger Medical Products, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
127d
Days
Class 2
Risk

K102713 is an FDA 510(k) clearance for the TIGER FLAT SURGICAL 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 January 25, 2011 after a review of 127 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 - K102713

510(k) Number K102713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date January 25, 2011
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
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 548
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K102713.
SURGICAL MASKS
K111559 · Shanghai Neo-Medical Import & Export Co., Ltd. · Sep 2011
SURGICAL FACE MASK
K110027 · Angeline Group , Ltd. · Aug 2011
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
K103303 · Crosstex International, Inc. · Dec 2010
SURGICAL FACE MASK
K093901 · Epard Protective Products, Ltd. · Sep 2010
IMC SURGICAL FACE MASK
K100846 · International Medsurg Connection · Aug 2010