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Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160467
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/2/2016
Days to Decision
165 days
Submission Type
Statement

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160467
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/2/2016
Days to Decision
165 days
Submission Type
Statement