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510(k) Data Aggregation
K Number
K072359Device Name
AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
Manufacturer
Date Cleared
2007-11-08
(78 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AEARO COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aearo Surgical N95 Respirators, N9508C and N9511 are NIOSH approved N95 respirators 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Device Description
These masks are molded cup masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 elastic headbands. No fiberglass media is used in this product.
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K Number
K070168Device Name
N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
Manufacturer
Date Cleared
2007-04-18
(90 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AEARO COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aearo Surgical N95 Respirators, N9504C, N9504CS and N9514 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. This includes use as a procedure mask. isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Device Description
These masks are molded cup masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 elastic headbands. No fiberglass media is used in this product.
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K Number
K063013Device Name
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
Manufacturer
Date Cleared
2006-12-01
(60 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AEARO COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pleats Plus ™ 1054 and 1054S N95 Respirators and Surgical Masks 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Device Description
These masks are pleated, 3-ply masks, with a center layer of polypropylene meltblown material sandwiched 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 wearers nose. No fiberglass media is used in this product.
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