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510(k) Data Aggregation
K Number
K211260Device Name
Sheng Jing Tang Surgical Mask
Manufacturer
Date Cleared
2022-01-10
(259 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Liaoning Shengjingtang Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sheng Jing Tang 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 Sheng Jing Tang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (Spun-bond polypropylene), Inner layer (Spun-bond polypropylene), Middle Layer filter (Polypropylene Melt-blown Cloth), 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 Sheng Jing Tang Surgical Masks are single use, disposable device, adult only, provided non-sterile.
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