Search Results
Found 1 results
510(k) Data Aggregation
K Number
K230577Device Name
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Date Cleared
2023-08-16
(168 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sterile Triplex Surgical Gown (S, M, L, XL, XXL, is a sterile single-use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1