Cleared Abbreviated

K122717 - FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K122717 · Tiger Medical Products, Ltd. · General Hospital
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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.

View all Tiger Medical Products, Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 128d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 606
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