K231938
- 510(k) 号
- K231938
- 器械名称
- 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
- 申请人
- O&M Halyard, Inc. GA · US
- 产品代码
- LZA — Polymer Patient Examination Glove
- 批准日期
- 2024-03-22
- 受理日期
- 2023-06-30
- 决定
- Substantially Equivalent
- 审查途径
- Abbreviated
- 咨询委员会
- General Hospital
510(k) Summary（FDA 官方 PDF）： K231938.pdf
FDA 官方记录： K231938
数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。