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510(k) Data Aggregation
K Number
K223270Device Name
POSE Health Care Surgical Mask
Manufacturer
Date Cleared
2022-11-01
(8 days)
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
America's Supply Chains
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The POSE™ Health Care Surgical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
POSE™ Health Care Surgical Mask is composed of three-layers and is flat fold. The mask materials consist of an outer cover web (polypropylene spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.
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