K231938
- 510(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. GA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-03-22
- Date received
- 2023-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K231938.pdf
Official FDA record: K231938
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.