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510(k) Data Aggregation
K Number
K212059Device Name
Surgical Face Mask
Date Cleared
2021-12-17
(169 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Zhongshan Saifute Labor Protective Articles CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Face 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. This is a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Face Mask is composed of mask body, nose clip and ear loops. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex. The size of the Surgical Face Mask is 17.5*9.5cm with tolerance ± 5% cm, the length of the ear loopis 16cm, and the length of the nose clip should no less than 8.0cm. The outer layer of Surgical Face Mask will be provided in blue, the inner layer of the Surgical Face Mask will be provided in white. The Surgical Face Mask will be provided non-sterile and is intended to be single use.
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