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
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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.

View all Jingzhou Haixin Green Cross Medical Products Co.,L devices

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 456
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
K140155 · Cardinal Health200, LLC · Jun 2014
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972849 · Cypress Medical Products, Ltd. · May 1998