Last synced on 11 July 2025 at 11:06 pm

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
FDA Hosted 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
FDA Hosted 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