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N9504C, N9504CS and N9514C Surgical N95 Respirators 510(k) Summary APR 1 8 2007 Surgical Mask or Surgical N95 Respirator Classification CFR Section 21 CFR 878.4040 Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Oct 15, 2009 · A surgical N95 respirator is a NIOSH approved N95 respirator that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask. These products are noted in bold font on the table of NIOSH approved N95 respirators. For your convenience, view a comprehensive table of these products. If you have a product that you believe is

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Trade/Device NameN95 Particulate Respirator and Surgical Mask, Models TN01 11 and TN01 12 Regulation Number21 CFR 878.4040 Regulation NameSurgical Apparel Regulatory ClassII Product CodeMSH Parts 800 to 898. In addition, FDA may

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If you have a product you believe is NIOSH approved and FDA cleared that does not appear on this list, you will need to check with the FDA Center for Devices and Radiological Health at 1 800 638 2041 for validation of clearance. View a comprehensive table of Surgical N95 Respirators.

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N95 Surgical Particulate Respirators

Surgical respirators are a type of respiratory protection that offers the combined protective properties of both a filtering facepiece respirator and a surgical mask. Surgical N95 respirators are certified by NIOSH as respirators and also cleared by FDA as medical devices which have been designed and tested and shown to be equivalent to

Surgical Mask :B2BManufactures For Taiwan and China

Full listing of Surgical Masks manufacturer & surgery mask suppliers online. We have a broad range of surgical face mask and services which can be sourced by this comprehensive vertical web portal dedicated to helping global buyers searching and purchasing from Taiwan and China surgical masks manufacturers. Inquires are welcome from worldwide agents, importers, chain stores, distributors and

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In addition to the barrage of filtration, bacterial, droplet, pressure, splash and flammability testing that a proper surgical face mask must undergo to secure its U.S. Food and Drug Administration (FDA), American Society of Testing Materials (ASTM) or International Organization for Standardization (ISO) classification and approval, it must be

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