Securities code: 002082 securities abbreviation: Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) Announcement No.: 2022-003
Wanbangde Pharmaceutical Holding Group Co.Ltd(002082)
Announcement on the subsidiary's medical surgical mask passing the audit of fda510 (k) in the United States
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Recently, Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) Medical Technology Co., Ltd. (hereinafter referred to as Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) medical), a holding subsidiary of Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) (hereinafter referred to as "the company"), received a notice from the U.S. Food and Drug Administration (hereinafter referred to as "the FDA") that Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) medical surgical mask officially passed the review of FDA 510 (k). The relevant information is hereby announced as follows: I. main contents of product approval
Trade / device name: medical surgical mask
510 (k) code [510 (k) number]: k212299
Regulation number: 21 CFR 878.4040
Regulation Name: surgical apparel
Regulatory class: Class II
Product Code: FXX
2、 Product structure and Application
The medical surgical mask is a disposable flat pleated mask. The inner and outer layers of the mask are polypropylene non-woven fabric, the middle layer is polypropylene melt blown fabric, the nose clip is made of polypropylene and iron wire, and the earrings are made of spandex. This medical surgical mask is for one-time use only and is provided in a non sterile form.
Medical surgical masks are designed to prevent the transfer of microorganisms, body fluids and particulate matter between patients and medical staff, and reduce potential contact between blood and body fluids.
3、 Impact on the company
The company's medical surgical mask products have passed the review of FDA 510 (k), which indicates that the medical surgical mask produced by the company has obtained the entry qualification of the American market, which is conducive to further increasing the comprehensive competitiveness of the company's products to explore the international market, driving the development of the company's original medical protective mask business, and will have a positive impact on the company's future operation. However, the sales of the above products of the company will be affected by factors such as changes in international trade policies and environment. At present, the company is unable to predict its specific impact on the company's future performance. Please pay attention to investment risks.
It is hereby announced.
Wanbangde Pharmaceutical Holding Group Co.Ltd(002082)
Board of directors
January 13, 2002
