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Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

Page Type
Cleared 510(K)
510(k) Number
K161006
510(k) Type
Traditional
Applicant
HARTALEGA SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/4/2016
Days to Decision
115 days
Submission Type
Statement

Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

Page Type
Cleared 510(K)
510(k) Number
K161006
510(k) Type
Traditional
Applicant
HARTALEGA SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/4/2016
Days to Decision
115 days
Submission Type
Statement