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Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213548
510(k) Type
Traditional
Applicant
Mercator Medical (Thailand) LTD
Country
Thailand
FDA Decision
Substantially Equivalent
Decision Date
2/21/2022
Days to Decision
105 days
Submission Type
Statement

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213548
510(k) Type
Traditional
Applicant
Mercator Medical (Thailand) LTD
Country
Thailand
FDA Decision
Substantially Equivalent
Decision Date
2/21/2022
Days to Decision
105 days
Submission Type
Statement