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510(k) Data Aggregation
K Number
K092580Device Name
TIDI FACEMASK
Manufacturer
TIDI PRODUCTS,LLC
Date Cleared
2010-02-23
(186 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
TIDI PRODUCTS,LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Device Description
The TIDI® Facemask, are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% SBPP or 100% medical grade tissue paper. The ear loops are made of latex free elastic. The nosepieces are made of malleable aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The mask covers the nose and mouth, and is secured to the face using the attached ear loops. The TIDI® Facemasks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body fluids and particulate material.
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