Last synced on 25 January 2026 at 3:41 am

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

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200581
510(k) Type
Traditional
Applicant
Hartalega NGC Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
4/25/2020
Days to Decision
51 days
Submission Type
Statement

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

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200581
510(k) Type
Traditional
Applicant
Hartalega NGC Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
4/25/2020
Days to Decision
51 days
Submission Type
Statement