FDA 510(k)

NitriTec 聚氯乙烯手套无粉蓝色

K号: K210460 · 2021-05-17

申请人Zhonghong Pulin Medical Products Co., Ltd.

决定日期2021-05-17

产品代码LYZ

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

NitriTec Vinyl Glove Powder Free Blue is the device name listed in this FDA 510(k) record. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-05-17 under 510(k) number K210460. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NitriTec Vinyl Glove Powder Free Blue?

NitriTec Vinyl Glove Powder Free Blue is a medical device that received FDA 510(k) clearance on 2021-05-17. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. The 510(k) number is K210460.

When did NitriTec Vinyl Glove Powder Free Blue receive FDA 510(k) clearance?

NitriTec Vinyl Glove Powder Free Blue received FDA 510(k) clearance on 2021-05-17, under 510(k) number K210460.

Who is the listed applicant for NitriTec Vinyl Glove Powder Free Blue?

The FDA 510(k) record lists Zhonghong Pulin Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NitriTec Vinyl Glove Powder Free Blue?

The FDA product code for NitriTec Vinyl Glove Powder Free Blue is LYZ.

列明Zhonghong Pulin Medical Products Co., Ltd.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。

K231029丙烯酸丁腈检查手套，用于化疗药物和芬太尼测试 K230662丙烯酸丁腈检查手套，加长袖口，用于化疗药物、芬太尼柠檬酸盐和选定的其他药物测试 K171873无粉乳胶患者检查手套，蓝色着色，非无菌，用于化疗药物测试 K152712丁腈粉末无粉病人检查手套，蓝色

官方来源

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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。