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510(k) Data Aggregation
K Number
K211773Device Name
Single-use Surgical Mask
Manufacturer
Date Cleared
2021-12-02
(177 days)
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Taiwan Seafood and Fish Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device provided non-sterile.
Device Description
The Single-Use Surgical Mask is a 3-ply, disposable surgical face mask. The outer and inner layers of the mask are made of spunbond polypropylene, while the middle layer consists of a meltblown polypropylene filter fabric. The device is secured on the user's face via elastic earloops and are labeled non-sterile, single-use, and disposable. This device is a surface device intended to come in contact with intact skin for a duration of less than 24 hours.
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