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510(k) Data Aggregation
K Number
K212740Device Name
Puravita Medical Fold Flat Surgical Mask
Manufacturer
Date Cleared
2021-12-02
(94 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Puravita M, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device that is provided non-sterile.
Device Description
The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with natural rubber latex.
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