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510(k) Data Aggregation
K Number
K040333Device Name
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
Manufacturer
VALUMAX INTL., INC.
Date Cleared
2004-06-07
(117 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
VALUMAX INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ValuMax" Surgical Masks is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
Device Description
ValuMax" Surgical Masks are pleated 3-ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. The nose piece for all ValuMax® Face Masks is malleable aluminum wire. Fog free masks have an anti-fog strip. Masks with splash visors have anti-fog treated plastic shield attached to masks. All of the material used in the construction of the ValuMax® Surgical Masks are being used in currently marketed devices (see predicate information).
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