FDA 510(k) Applications Submitted by O & M Halyard, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K182851 |
10/10/2018 |
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
O & M Halyard, Inc. |
| K183132 |
11/13/2018 |
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
O & M Halyard, Inc. |
| K191230 |
05/08/2019 |
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves |
O & M Halyard, Inc. |
| K211063 |
04/09/2021 |
HALYARD Flexaprene Green Powder-Free Exam Glove |
O & M Halyard, Inc. |
| K202622 |
09/10/2020 |
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate |
O & M Halyard, Inc. |
| K213929 |
12/16/2021 |
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
O & M Halyard, Inc. |
| K213937 |
12/16/2021 |
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 |
O & M Halyard, Inc. |
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