Last synced on 27 June 2025 at 11:06 pm

Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored 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
K210401
510(k) Type
Traditional
Applicant
Ansell Healthcare Products LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2021
Days to Decision
123 days
Submission Type
Summary

Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored 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
K210401
510(k) Type
Traditional
Applicant
Ansell Healthcare Products LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2021
Days to Decision
123 days
Submission Type
Summary