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Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160560
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/4/2016
Days to Decision
157 days
Submission Type
Statement

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160560
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/4/2016
Days to Decision
157 days
Submission Type
Statement