Cardinal Health 氮化橡胶检查手套，延长袖口
K号: K252313 · 2026-01-14
广告
决定日期2026-01-14
产品代码LZC
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Cardinal Health Nitrile Examination Gloves Extended Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2026-01-14 under 510(k) number K252313. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cardinal Health Nitrile Examination Gloves Extended Cuff?
Cardinal Health Nitrile Examination Gloves Extended Cuff is a medical device that received FDA 510(k) clearance on 2026-01-14. The listed applicant is Cardinalhealth. The 510(k) number is K252313.
When did Cardinal Health Nitrile Examination Gloves Extended Cuff receive FDA 510(k) clearance?
Cardinal Health Nitrile Examination Gloves Extended Cuff received FDA 510(k) clearance on 2026-01-14, under 510(k) number K252313.
Who is the listed applicant for Cardinal Health Nitrile Examination Gloves Extended Cuff?
FDA 510(k)记录显示Cardinalhealth为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Cardinal Health Nitrile Examination Gloves Extended Cuff?
The FDA product code for Cardinal Health Nitrile Examination Gloves Extended Cuff is LZC.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Cardinalhealth为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K261749Cardinal Health 硝基蓝检查手套，经测试可用于化疗药物和芬太尼盐酸盐使用K243660Monoject® 1mL 结核菌素注射器 Luer-Lock 尖端 (1180100777); Monoject® 3mL 注射器，Luer-Lock 尖端 (1180300777); Monoject® 6mL 注射器，Luer-Lock 尖端 (1180600777); Monoject® 12mL 注射器，Luer-Lock 尖端 (1181200777); Monoject® 20mL 注射器，Luer-Lock 尖端 (1182000777); Monoject® 35mL 注射器，Luer-Lock 尖端 (1183500777); Monoject® 60mL 注射器，Luer-Lock 尖端 (1186000777); Monoject® 3mL 注射器，Luer-Lock 尖端 (8881513934); Monoject® 6mL 注射器 , Luer-Lock 尖端 (8881516937); MonojecK243652Monoject® Enteral Syringe with ENFit Connector (401SE); Monoject® Enteral Syringe with ENFit Connector (403SE); Monoject® Enteral Syringe with ENFit Connector (406SE); Monoject® Enteral Syringe with ENFit Connector (412SE); Monoject® Enteral Syringe with ENFit Connector (435SE); Monoject® Enteral Syringe with ENFit Connector (460SE)K230569Cardinal Health防雾水凝胶手术口罩（3级）；Cardinal Health防雾水凝胶手术口罩（1级）K213174Salem Sump 硅胶双腔胃管带 ENFit 连接K202217Kendall NPWT 切口管理设备
相关器械（代码：LZC）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K243959无尘乳胶检查手套（紫色，黑色，绿色），经测试可用于化疗药物，芬太尼盐酸盐和选定的其他药物Lingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449丁腈粉末无粉检查手套，经测试可用于化疗药物和芬太尼盐酸盐（深蓝色）Better Care Plastic Technology Co., Ltd.K220545无粉乳胶检查手套，蓝色，用于化疗药物测试Hl Rubber Industries Sdn BhdK220491一次性医用检查丁腈手套 - 经化疗药物测试Hainan Asther Medical Equipment Co., Ltd.K220353废弃医用丁腈检查手套-用于化疗药物测试Niujian Technology Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告