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Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162405
510(k) Type
Traditional
Applicant
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/28/2017
Days to Decision
211 days
Submission Type
Summary

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162405
510(k) Type
Traditional
Applicant
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/28/2017
Days to Decision
211 days
Submission Type
Summary