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510(k) Data Aggregation
K Number
K140147Device Name
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
Manufacturer
Date Cleared
2014-04-22
(90 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL CARBON TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BCT Antimicrobial Dressing & BCT Silver Bandage Dressings are intended for the management of wounds and to provide an antimicrobial barrier. These dressings are applied topically and are in direct contact with the wound. Both are intended to be used for indications such as:
- Partial and full thickness wounds;
- Pressure ulcers;
- Diabetic ulcers;
- Surgical wounds;
- Acute wounds ( 1st and 2nd degree burns )
Device Description
BCT Antimicrobial Dressing consists of polyethylene terphthalate (PET) non-woven, silver-coated activated carbon fiber cloth and polyethylene (PE) film. BCT Silver Bandage contains the same ingredients, but includes an adhesive layer. The dressings and bandages contain 100 µg/cm² of silver and are available in several sizes to accommodate different wound sizes.
BCT Antimicrobial Dressing and BCT Silver Bandage absorbs wound fluid and exudates containing infectious organisms into the dressing fabric, where the silver exerts its antimicrobial action. The silver ions act locally within the dressing, eliminating the absorbed bacteria and pathogens.
The activated carbon fiber cloth in BCT Dressings absorbs bacterial toxins and offensive odors.
The dressings are individually packaged in a pouch. All dressings are sterile and are for single use only.
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