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FDA 510(k)

Nugard 无黑粉乳胶检查手套,聚合物涂层,含水量50微克或以下的可提取物蛋白

K号: K170779 · 2017-05-24

决定日期2017-05-24
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

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein is the device name listed in this FDA 510(k) record. The listed applicant is Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K170779. 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 Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein?

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Terang Nusa Sdn Bhd. The 510(k) number is K170779.

When did Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein receive FDA 510(k) clearance?

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein received FDA 510(k) clearance on 2017-05-24, under 510(k) number K170779.

Who is the listed applicant for Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein?

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

What is the FDA product code for Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein?

The FDA product code for Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein is LYY.

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Terang Nusa Sdn Bhd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。

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。

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。

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