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ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061074
510(k) Type
Traditional
Applicant
BRIGHT ELEMENT SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/24/2006
Days to Decision
37 days
Submission Type
Statement

ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061074
510(k) Type
Traditional
Applicant
BRIGHT ELEMENT SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/24/2006
Days to Decision
37 days
Submission Type
Statement