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Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162095
510(k) Type
Traditional
Applicant
YTY INDUSTRY (MANJUNG) SDN. BHD.,
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/2/2016
Days to Decision
97 days
Submission Type
Summary

Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162095
510(k) Type
Traditional
Applicant
YTY INDUSTRY (MANJUNG) SDN. BHD.,
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/2/2016
Days to Decision
97 days
Submission Type
Summary