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LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142270
510(k) Type
Traditional
Applicant
HARTALEGA SDB. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/25/2014
Days to Decision
102 days
Submission Type
Statement

LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142270
510(k) Type
Traditional
Applicant
HARTALEGA SDB. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/25/2014
Days to Decision
102 days
Submission Type
Statement