Last synced on 25 January 2026 at 3:41 am

Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, 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
K241909
510(k) Type
Abbreviated
Applicant
O&M Halyard, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2024
Days to Decision
88 days
Submission Type
Summary

Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, 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
K241909
510(k) Type
Abbreviated
Applicant
O&M Halyard, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2024
Days to Decision
88 days
Submission Type
Summary