O&M Halyard, Inc. · Class I · Cleared Mar 22, 2024
| K-number | K231938 |
| Device name | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid |
| Applicant | O&M Halyard, Inc. |
| Product code | LZA |
| Device class | Class I |
| Decision date | Mar 22, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
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