APPROVED BY THE CDC FOR USE IN HEALTHCARE

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Our mission is to consistently provide reliable products that can deliver value to customers in health care and protection.

Buda-U's KN95 and 3-PLY masks have been put into our major products portfolios. We produce over 200,000 KN95 respirators and over 150,000 disposable 3-ply masks a day.

Our dust-free workshops are running 24 hours a day in order to meet the increasing demand of our protective products for our customers across the globe.

The FDA has issued an Emergency Use Authorization for Purifa Medical Production Co. Ltd. KN95 Respirator Product # BU-E978

On September 28, 2020 the FDA authorized BU-E978 as an Imported, Non-NIOSH Approved Respirator Manufactured in China to be used in Healthcare Facilities in the USA.

FDA Site

Fiscal Year 2020 Certification of Registration

Purifa Medical Production Co. LTD has been registered with the FDA with Owner/Operator number 10066481.

Verify on FDA

Fiscal Year 2020 Certification of Registration

Our products have been registered with the FDA under the Respirator, Surgical category coded MSH.
Our KN95 Particulate Respirator Mask has been registered with the FDA with product number BU-E978.
Our 3-Ply Disposable Face Mask has been registered with the FDA with product number BU-E508.

FDA Device Listing

Ella Import Export LLC

We are the official reseller of PURIFA Medical Production Co., Ltd. and of Buda-U branded products in the USA.
We ship to all US states the same business day from our warehouse in New Jersey.
Our e-shop www.directfacecovers.com is hosted on Shopify for maximun security and protection.
For any further information or question about our products, please contact us.