Search Results
Found 1 results
510(k) Data Aggregation
K Number
K250502Device Name
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
Manufacturer
SafeSource Direct LLC
Date Cleared
2025-03-19
(27 days)
Product Code
LZA, LZC, OPJ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SafeSource Direct LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove
Ask a Question
Page 1 of 1