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510(k) Data Aggregation
K Number
K210388Device Name
Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color
Manufacturer
Mexpo International Inc.
Date Cleared
2021-12-13
(307 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mexpo International Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.
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K Number
K200847Device Name
Surgical Face Mask
Manufacturer
Mexpo International Inc.
Date Cleared
2020-04-23
(23 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Mexpo International Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.
Device Description
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
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