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NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133956
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/28/2014
Days to Decision
156 days
Submission Type
Summary

NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133956
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/28/2014
Days to Decision
156 days
Submission Type
Summary