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510(k) Data Aggregation
K Number
K221957Device Name
Savewo ClassicMASK
Manufacturer
Date Cleared
2022-09-02
(59 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Savewo Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Savewo ClassicMASKs are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
This is a single use, disposable device(s) and provided non-sterile.
Device Description
Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.
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