Cleared Traditional

K043199 - SURGICAL FACE MASK

K043199 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 90-day FDA review.

K043199 · 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
Feb 2005
Decision
90d
Days
Class 2
Risk

K043199 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 February 16, 2005 after a review of 90 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 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 - K043199

510(k) Number K043199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2004
Decision Date February 16, 2005
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 K043199.
SURGICAL FACE MASK
K060776 · Hong YA Non-Woven Products Co., Ltd. · May 2006
SURGICAL FACE MASK
K050689 · China Surgical Dressings Center Co., Ltd. · Oct 2005
NON-STERILE SURGICAL MASK
K051291 · A.R. Medicom, Inc. · Sep 2005
PROTECTION PLUS EARLOOP PROCEDURE MASK
K042654 · Safety-Med Products, Inc. · Dec 2004
ULTRADENT CARBON MASK - UPI #342
K041047 · Medspring Group, Incorporated · Dec 2004
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
K040333 · Valumax Intl., Inc. · Jun 2004
K043199 · SURGICAL FACE MASK
Download PDF FDA Summary Hong YA Non-Woven Pro…