Last synced on 27 June 2025 at 11:06 pm

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213937
510(k) Type
Abbreviated
Applicant
O & M Halyard, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2022
Days to Decision
243 days
Submission Type
Summary

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213937
510(k) Type
Abbreviated
Applicant
O & M Halyard, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2022
Days to Decision
243 days
Submission Type
Summary