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510(k) Data Aggregation
K Number
K220377Device Name
Procedure Mask
Manufacturer
Date Cleared
2022-06-24
(134 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Little Rapids Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Procedure Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. All models are single use, disposable devices, provided non-sterile.
Device Description
Model GFM31A Procedure Mask will be provided with a nose wire for general medical use, and without a nose wire for use in an MRI environment. This model of Procedure Mask is manufactured with three layers. The user facing layer is made of white polypropylene spunbond; the filtration/middle layer is made of white polypropylene meltblown; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire, when present, is used to fit the facemask around the user's nose. The product intended to be used in an MRI environment is constructed with the same materials except for the nose wire. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
Model GFM42A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
Model GFM43A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
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