Search Results
Found 1 results
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1