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510(k) Data Aggregation
K Number
K213136Device Name
CPL Surgical Face Mask
Manufacturer
Date Cleared
2021-12-24
(88 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Control Print Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The surgical face mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only, Available models: Surgical Face Mask EL (Ear loops) Surgical Face Mask TO (Tie-on)
Device Description
The CPL Surgical Face Mask is a 3-ply flat-pleated mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core galvanized wire. The model Surgical Face Mask EL is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of braided elastic band. The model Surgical Face Mask TO is provided with non-woven tie-on string. The dimensions of the test item are: length- 175 ± 5 mm and width- 95 ± 5 mm. The ear loop length of the model Surgical Face Mask EL is 170± 5 mm. The tie-on of the model Surgical Face Mask TO has a top strap length of 410 ± 10 mm and bottom strap length of 385 ± 10 mm. The surgical masks are single-use, disposable devices, provided non-sterile.
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