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FDA 510(k)

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE

K号: K162626 · 2017-03-31

申请人Top Quality Glove Sdn. Bhd
决定日期2017-03-31
产品代码LZA
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

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Top Quality Glove Sdn. Bhd. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162626. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Top Quality Glove Sdn. Bhd. The 510(k) number is K162626.

When did THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE receive FDA 510(k) clearance?

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162626.

Who is the listed applicant for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?

The FDA 510(k) record lists Top Quality Glove Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?

The FDA product code for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is LZA.

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。

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相关器械（代码：LZA）

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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官方来源

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