Last synced on 27 June 2025 at 11:06 pm

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201531
510(k) Type
Traditional
Applicant
Hartalega SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/5/2020
Days to Decision
58 days
Submission Type
Statement

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201531
510(k) Type
Traditional
Applicant
Hartalega SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/5/2020
Days to Decision
58 days
Submission Type
Statement