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510(k) Data Aggregation
K Number
K202905Device Name
Disposable Face Mask
Manufacturer
Date Cleared
2021-03-26
(178 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Excellence Medical Supplies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable 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, provided non-sterile.
Device Description
The proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.
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K Number
K201324Device Name
Antibacterial Bandage
Manufacturer
Date Cleared
2021-02-05
(263 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Jiangsu Excellence Medical Supplies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Antibacterial bandage is to be applied topically to the skin for management of minor scrapes and minor burns.
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.
Device Description
The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. The proposed devices are available in fabric backing and plastic backing. All of devices consist of (1) backing (fabric or plastic), (2) absorbent pad (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride) and (3) release paper (composed of cellulose pulp, water, kaolin, starch, ethanol and ethylene copolymer). Each device type is available in several models. The difference between each model is the device size. This dressing contains 0.08% benzalkonium chloride which has shown effectiveness against (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans and Aspergillus Niger) for up to 24 hours, as demonstrated via in vitro testing.
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