Cleared Traditional

K050689 - SURGICAL FACE MASK

K050689 is an FDA 510(k) clearance for SURGICAL FACE MASK, manufactured by China Surgical Dressings Center Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K050689 · China Surgical Dressings Center Co., Ltd. · General Hospital
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Oct 2005
Decision
223d
Days
Class 2
Risk

K050689 is an FDA 510(k) clearance for the SURGICAL FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by China Surgical Dressings Center Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on October 26, 2005 after a review of 223 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 China Surgical Dressings Center Co., Ltd. devices

FDA 510(k) Submission Details - K050689

510(k) Number K050689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2005
Decision Date October 26, 2005
Days to Decision 223 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
94d slower than avg
Panel avg: 129d · This submission: 223d
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 485
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K050689.
SURGICAL FACE MASK
K110027 · Angeline Group , Ltd. · Aug 2011
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
K103303 · Crosstex International, Inc. · Dec 2010
HENRY SCHEIN SURGICAL MASK
K992604 · Mitsui Textile Corp. · Jan 2000
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999
EARLOOP FACE MASK
K990719 · Shuenn Bao Shing Corp. · Jul 1999