At present, the quality of epidemic prevention products are uneven. Hubei Woozon Healthcare Co.,Ltd has a set of mature quality management system in operation, from supplier development management to production process management, testing and verification management, each link and key points are equipped with QC posts and advanced fully automated testing equipment, the whole process monitoring zero dead corners, to ensure that the product delivery rate of 100%. However, before 2023, our company did not obtain the FDA registration certificate, and medical surgical face masks could not enter the US market. After many inquiries from colleagues, consultation and declaration from many agencies, it took more than one year, and finally welcomed the good news. We have FDA registration.

1.Device Information

Trade name: Surgical Face Mask

Model: Ear-loop Type

Production code: FXX

Regulation number: 21CFR 878.4040

Classification: Class II

Panel: Surgical Apparel

2. Device Description

The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops and

nose piece. The Surgical Face Mask is manufactured with three layers, the inner and

outer layers are made of polypropylene, and the middle layer is made of melt blown

polypropylene filter. The ear loops are held in place over the users’ mouth and nose

by two elastic ear loops welded to the facemask. The elastic ear loops are not made

with natural rubber latex. The nose piece in the layers of facemask is to allow the user

to fit the facemask around their nose, which is made of Galvanized iron wire. The

Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as

non-sterile and are intended to be single use, disposable devices.

3.Indication for Use Statement

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.