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Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223437
510(k) Type
Traditional
Applicant
Hartalega NGC SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/17/2023
Days to Decision
184 days
Submission Type
Summary

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223437
510(k) Type
Traditional
Applicant
Hartalega NGC SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/17/2023
Days to Decision
184 days
Submission Type
Summary