Search Results
Found 1 results
510(k) Data Aggregation
K Number
K983962Device Name
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
Manufacturer
Date Cleared
1999-01-08
(63 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The Ultrafree Textured Surgical gloves are formulated using natural rubber latex and offered powder-free and sterile.
Ask a Question
Ask a specific question about this device
Page 1 of 1