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GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243796
510(k) Type
Traditional
Applicant
Glove One, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/3/2025
Days to Decision
175 days
Submission Type
Summary

GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243796
510(k) Type
Traditional
Applicant
Glove One, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/3/2025
Days to Decision
175 days
Submission Type
Summary