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Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232064
510(k) Type
Traditional
Applicant
Isikel Manufacturing LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/2/2023
Days to Decision
83 days
Submission Type
Summary

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232064
510(k) Type
Traditional
Applicant
Isikel Manufacturing LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/2/2023
Days to Decision
83 days
Submission Type
Summary