Cleared Traditional

K060776 - SURGICAL FACE MASK

K060776 is an FDA 510(k) clearance for SURGICAL FACE MASK, manufactured by Hong YA Non-Woven Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K060776 · Hong YA Non-Woven Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
64d
Days
Class 2
Risk

K060776 is an FDA 510(k) clearance for the SURGICAL FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Hong YA Non-Woven Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on May 25, 2006 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060776

510(k) Number K060776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2006
Decision Date May 25, 2006
Days to Decision 64 days
Submission Type Traditional
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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 601
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K060776.
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
K063043 · Modern Healthcare Corp. · Mar 2007
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530
K061864 · Dukal Corp. · Sep 2006
PRESTIGE AMERITECH FACE MASK
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SURGICAL FACE MASK
K050689 · China Surgical Dressings Center Co., Ltd. · Oct 2005
NON-STERILE SURGICAL MASK
K051291 · A.R. Medicom, Inc. · Sep 2005
SURGICAL FACE MASK
K043199 · Hong YA Non-Woven Products Co., Ltd. · Feb 2005
K060776 · SURGICAL FACE MASK
Download PDF FDA Summary Hong YA Non-Woven Pro…