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Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180786
510(k) Type
Traditional
Applicant
HARTALEGA SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/2/2018
Days to Decision
221 days
Submission Type
Statement

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180786
510(k) Type
Traditional
Applicant
HARTALEGA SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/2/2018
Days to Decision
221 days
Submission Type
Statement