fda 510k en14683 cough face masks

fda 510k en14683 cough face masks

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Founded in 2000, the company has 20 years of experience in the production and processing of medical materials. At present, the company has a sound r & d, production, sales, service system, has become an outstanding manufacturer in China's medical supplies industry, and internationally renowned enterprises to compete in the world market.

Clean has an annual value of $1 billion. Enough to affect the entire Asian region, and even the world's medical supplies production situation..

Covering an area of more than 300,000 square meters, it has 6 domestic first-class production bases and one of the world's largest mask and protective clothing manufacturers.

Clean sales net covers over 160 countries and regions from different continents.




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Surgical Masks - Premarket Notification [510(k ...

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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China FDA 510K/EN14683 Surgical Mask manufacturer Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd. provides kinds of FDA 510K/EN14683 Surgical Mask. Welcome to know more about FDA 510K/EN14683 Surgical Mask.

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Face masks are categorised into Surgical Mask and other common Face Masks depending on performance level. The WELLMIEN range of surgical masks meet the requirements of FDA 510(k) and EN14683. The US Standard for surgical masks FDA 510(k) and European Standard EN14683 define strict performance requirements for surgical masks in order to ensure a consistent level of quality.

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About – Free sample support from China

Aonousi is implementing a strict Quality Management System (QMS) and ISO 13485:2003 certified. Our main products also have passed CE certification of European Union (EU) and have FDA Medical Device Listing. Aonousi Surgical Masks meet EN14683 standard of EU, and also have acquired FDA 510(K).

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