Cleared Traditional

K123787 - GREENCROSS SURGICAL MASK

K123787 is an FDA 510(k) clearance for GREENCROSS SURGICAL MASK, manufactured by Jingzhou Haixin Green Cross Medical Products Co.,L. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K123787 · Jingzhou Haixin Green Cross Medical Products Co.,L · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
219d
Days
Class 2
Risk

K123787 is an FDA 510(k) clearance for the GREENCROSS SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Jingzhou Haixin Green Cross Medical Products Co.,L (Acton, US). The FDA issued a Cleared decision on July 17, 2013 after a review of 219 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.

FDA 510(k) Submission Details - K123787

510(k) Number K123787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date July 17, 2013
Days to Decision 219 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 129d · This submission: 219d
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 557
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K123787.
Insta-Gard Surgical and Procedure Face Mask
K142990 · Cardinal Health200, LLC · Mar 2015
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
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K131879 · Kimberly-Clark Corp. · Dec 2013
ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
K123115 · Acme Filter Mask, Inc. · May 2013
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
K122717 · Tiger Medical Products, Ltd. · Dec 2012
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
K111402 · Kimberly-Clark · Oct 2011
K123787 · GREENCROSS SURGICAL MASK
Download PDF FDA Summary Jingzhou Haixin Green…