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510(k) Data Aggregation
K Number
K072067Device Name
N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
Manufacturer
Date Cleared
2008-01-08
(165 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
SHUENN BAO SHING CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Device Description
SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.
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