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Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171378
510(k) Type
Traditional
Applicant
SEMPERIT INVESTMENTS ASIA PTE. LTD.
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
9/14/2017
Days to Decision
127 days
Submission Type
Summary

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171378
510(k) Type
Traditional
Applicant
SEMPERIT INVESTMENTS ASIA PTE. LTD.
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
9/14/2017
Days to Decision
127 days
Submission Type
Summary