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510(k) Data Aggregation
K Number
K211487Device Name
MAF Guard
Manufacturer
Date Cleared
2021-12-08
(209 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
MAF Clothing Pvt Ltd Unit-3
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Device Description
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops or tie-on strings and a nose piece. The mask is 175 ± 5 mm by 95 ± 3 mm. The outer, blue layer and the inner, white layer are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. One model of the mask is secured to the face with two ear loops made of polyester Spandex that are 150 ± 10 mm long. The other model is secured with four spin bond polypropylene tie-on strings that are 450 ± 10 mm long. A nosepiece of steel core wire coated with polyethylene resin that is 110 ± 5 mm long conforms the mask to the shape of the nose.
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