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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200019
510(k) Type
Traditional
Applicant
Hartalega NGC Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
4/6/2020
Days to Decision
94 days
Submission Type
Statement

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200019
510(k) Type
Traditional
Applicant
Hartalega NGC Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
4/6/2020
Days to Decision
94 days
Submission Type
Statement