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510(k) Data Aggregation
K Number
K232333Device Name
Anti-bacterial bandage
Manufacturer
Date Cleared
2024-05-31
(301 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Jinhua Jingdi Medical Supplies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes.
Device Description
The Anti-bacterial bandage is EO sterilized and is for single use only. The bandage is made of three layers: Elastic Cloth (Fabric) type (Polyethylene terephthalate) or plastic type (Polyethylene), regenerated cellulose absorbent pad, and release liner (Glassine Release Paper). The absorbent pad contains 0.8% Benzalkonium chloride. Center non-woven absorbent pad is to absorb liquid, Benzalkonium chloride present in the pad is to reduce bacterial colonization within the dressing and backing adhesive (Liquid styrene polymer with 2-methyl-1,3-butadiene, White Mineral Oil, Petroleum Resins) layer is to keep the bandage in place.
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K Number
K210007Device Name
Face Mask
Manufacturer
Date Cleared
2021-04-23
(109 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Jinhua Jingdi Medical Supplies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Face Masks are 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. The Face Masks are single use, disposable devices, provided non-sterile.
Device Description
Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (Iron wire covered by polypropylene) to provide a firm fit over the nose.
There are two models for Face Mask with different colors and sizes.
For Type A model is in blue, barrier level 2 and size 145mm*95mm, ear loop type. For Type B model is in blue, barrier level 2 and size 175mm*95mm, ear loop type.
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