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510(k) Data Aggregation
K Number
K183681Device Name
Protego Antimicrobial Wound Dressing
Manufacturer
Date Cleared
2019-10-11
(287 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Global Health Solutions (DBA Turn Therapeutics)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Under the management of a healthcare professional, Protego Antimicrobial Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions.
Device Description
Protego Antimicrobial Wound Dressing is a sterile, single-use, non-adherent gauze dressing impregnated with an odorless petrolatum-based emulsion. The impregnated gauze is placed in a sealed pouch. The product contains Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK) to prevent microbial colonization within the dressing. Protego Antimicrobial Wound Dressing is intended to maintain a moist environment that is conducive to healing. Protego Antimicrobial Wound Dressingis packaged in single-use, LDPE tear pouches. Protego Antimicrobial Wound Dressing comes in three sizes, including 4"x 4," 1"x 8," and 2"x 2," with no differencein materials among the different sizes.
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