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Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162924
510(k) Type
Traditional
Applicant
HARTALEGA SDB. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
1/24/2017
Days to Decision
98 days
Submission Type
Statement

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162924
510(k) Type
Traditional
Applicant
HARTALEGA SDB. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
1/24/2017
Days to Decision
98 days
Submission Type
Statement