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LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT

Page Type
Cleared 510(K)
510(k) Number
K123368
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/7/2013
Days to Decision
187 days
Submission Type
Statement

LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT

Page Type
Cleared 510(K)
510(k) Number
K123368
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/7/2013
Days to Decision
187 days
Submission Type
Statement