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Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) 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.

The proposed Surgical Mask (Procedure Mask) body is a multi-layer construction of a Spun- bond polypropylene outer layer, meltblown middle layer and Spun-bond polypropylene inner layer. Nose clip is made of Aluminum plastic wire. There are two models of the proposed Surgical Mask (Procedure Mask), OH02-01 and OH02-01(Bandage). The main difference between each model is their wearing method, i.e. mask band part. For OH02-01 model, mask band part is made of non-woven fabric ear loops. For OH02-01(Bandage) model, mask band part is made of non-woven fabric ties. However, the raw materials of the two models devices are exactly the same. And have been tested according to ASTM F2100-19 Standard Specification For Performance Of Materials Used In Medical Face Masks. Surgical Mask (Procedure Mask) is a single use, disposable medical device that will be provided in non-sterile packaging configurations.