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N95 Respirators, Surgical Masks, and Face Masks | FDA

Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are not to be shared and may be labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without ...

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

The surgical masks referenced in this guidance document include masks that are labeled as a surgical, laser, isolation, dental or medical procedure masks with or without a face shield. Surgical ...

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FDA Requirements to Ship Face Masks to the USA | Registrar

Mar 06, 2020 · COVID-19 has made its way to the United States and has led to a nationwide shortage of face masks. Registrar Corp has received many requests from global manufacturers for assistance with U.S. Food and Drug Administration (FDA) regulations for exporting masks and other infection control devices to the USA in response.

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510(k) Premarket Notification

Medical Devices Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

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Dadsun Corporation Ltd. was established in 1976. The company originally started as a full line manufacturer and distributor of plastic products, including large nasal masks, Surgical Mask, hand-held medication nebulizers, and so on.Later our company was introduced by Taiwan International Trade Association to meet many international respiratory therapy companies.

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We are certified with ISO9001: 2008 International Quality Management System. The products meet Europe Standard EN149: 2001+A1: 2009 with FFP1 NR/ FFP2 NR/ FFP3 NR grades, Australia standard AS/NZS1716: 2003 and American standard NlOSH N95/ N99, FDA(510K), Japanese standard DS-2.

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