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Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213929
510(k) Type
Abbreviated
Applicant
O&M Halyard, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/1/2022
Days to Decision
228 days
Submission Type
Summary

Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213929
510(k) Type
Abbreviated
Applicant
O&M Halyard, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/1/2022
Days to Decision
228 days
Submission Type
Summary