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510(k) Data Aggregation
K Number
K092824Device Name
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
Manufacturer
Date Cleared
2009-10-21
(37 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ALPHAPROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Alpha Pro Tech's 695 N95 Respirator Mask meets the CDC guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It is intended to be a single use, disposable device. This would also include use as a procedure mask, isolation mask and/or dental face mask.
Device Description
Alpha Pro Tech's 695 N95 Respirator Masks consists of a polypropylene meltblown filter media sandwiched between non-woven wetlaid outer and inner covers. The mask is secured using two polyester covered non-latex rubber headbands. Fitting around the face is facilitated using a nose wire and an adjustable chin wire made from aluminum. No fiberglass media is used in this product.
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