FDA 510(k)

检查手套 - 类型 A(乳胶手套)

K号: K214017 · 2022-07-14

申请人Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

决定日期2022-07-14

产品代码LYY

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

Examination gloves-Type A(Latex gloves) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K214017. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Examination gloves-Type A(Latex gloves)?

Examination gloves-Type A(Latex gloves) is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K214017.

When did Examination gloves-Type A(Latex gloves) receive FDA 510(k) clearance?

Examination gloves-Type A(Latex gloves) received FDA 510(k) clearance on 2022-07-14, under 510(k) number K214017.

Who is the listed applicant for Examination gloves-Type A(Latex gloves)?

The FDA 510(k) record lists Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Examination gloves-Type A(Latex gloves)?

The FDA product code for Examination gloves-Type A(Latex gloves) is LYY.

列明Jiangxi Kemei Medical Apparatus & Instruments Group 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。

K211953一次性灭菌乳胶外科手套 K212290检查手套 - 类型 C (乳胶手套)

相关器械（代码：LYY）

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。

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