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510(k) Data Aggregation
K Number
K201549Device Name
Motex Anti-Fog Surgical Face Mask
Manufacturer
Modern Healthcare Corp.
Date Cleared
2020-08-26
(78 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Modern Healthcare Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Motex Anti-Fog Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Device Description
The Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, is flat pleated 3-ply device, which consists of four layers, i.e., Inner layer (Bicomponent thermal-bonded nonwoven, Polypropylene / Polyethylene, PP/PE), Filter layer (Polypropylene Melt-blown), Outer layer (Polypropylene Spunbond, blue/ green/ white/ pink color) and Anti-Fog films (EP coated Polyethylene). Each mask contains tie-on strips or elastic ear loops and of steel wire coated with Polyethylene resin to secure the mask fit over the user's mouth and nose. The dimensions of each mask are length 165±5 mm and width 95±2 mm.
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K Number
K191898Device Name
Sterile Latex Powder-Free Surgical Gloves
Manufacturer
Modern Healthcare Corp.
Date Cleared
2019-12-18
(155 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Modern Healthcare Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Device Description
Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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K Number
K063043Device Name
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
Manufacturer
MODERN HEALTHCARE CORP.
Date Cleared
2007-03-21
(169 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
MODERN HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.
Device Description
Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum wire. All the materials used in the construction of the Modern Healthcare Corp. Surgical Face Mask are being used in currently marked devices.
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