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510(k) Data Aggregation
K Number
K212203Device Name
Dong Hai Xiang Surgical Mask
Manufacturer
Taizhou Donghaixiang Protective Equipment Co., Ltd
Date Cleared
2022-04-07
(267 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Taizhou Donghaixiang Protective Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile
Device Description
The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter (Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.
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