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GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240545
510(k) Type
Traditional
Applicant
Genabio Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2024
Days to Decision
183 days
Submission Type
Summary

GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240545
510(k) Type
Traditional
Applicant
Genabio Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2024
Days to Decision
183 days
Submission Type
Summary