FDA 510(k)

天然乳胶检查手套，无粉，蛋白质含量标注（每克总可提取物蛋白质50ug或更少）

K号: K203705 · 2021-08-20

决定日期2021-08-20

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

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) is the device name listed in this FDA 510(k) record. The listed applicant is Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K203705. 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 Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)?

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Careplus (M) Sdn Bhd. The 510(k) number is K203705.

When did Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) receive FDA 510(k) clearance?

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) received FDA 510(k) clearance on 2021-08-20, under 510(k) number K203705.

Who is the listed applicant for Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)?

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

What is the FDA product code for Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)?

The FDA product code for Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) is LYY.

列明Careplus (M) 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。

K211621天然乳胶外科手套，无粉，蛋白质含量标注（50微克或更少）K201857无粉乳胶检查手套黑色和双色白-蓝 K210724ENCORE Latex Acclaim，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套50ug/dm2的总水溶性蛋白）并经过化疗药物使用测试，GAMMEX Latex Standard，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套50ug/dm2的总水溶性蛋白）并经过化疗药物使用测试 K210656ENCORE Latex Ortho，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套<50µg/dm2的总水溶性蛋白）并经过化疗药物使用测试，GAMMEX Latex Ortho，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套<50 µg/dm2的总水溶性蛋白）并经过化疗药物使用测试 K202765ENCORE Latex Textured Surgical Gloves，无粉，带有蛋白质含量标签声明（50微克或更少）并经过化疗药物使用测试 K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

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官方来源

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