Last synced on 6 June 2025 at 11:06 pm

NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140050
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
9/12/2014
Days to Decision
246 days
Submission Type
Statement

NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140050
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
9/12/2014
Days to Decision
246 days
Submission Type
Statement