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510(k) Data Aggregation
K Number
K201718Device Name
GD Disposable Medical Face Mask
Manufacturer
Date Cleared
2021-04-15
(296 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Guangda Medical Material Group Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GD Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
The GD Disposable Medical Face Mask is a single use multi-layer Level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours.
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