FDA 510(k)

一次性无粉聚氯乙烯检查手套，米色/透明

K号: K221980 · 2023-02-06

申请人Ever Global (Vietnam) Enterprise Corporation

决定日期2023-02-06

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

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. It received FDA 510(k) clearance on 2023-02-06 under 510(k) number K221980. 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 Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is a medical device that received FDA 510(k) clearance on 2023-02-06. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K221980.

When did Disposable Powder Free Vinyl Examination Gloves, Beige/Clear receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear received FDA 510(k) clearance on 2023-02-06, under 510(k) number K221980.

Who is the listed applicant for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?

The FDA product code for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is LYZ.

列明Ever Global (Vietnam) Enterprise Corporation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。

K252244一次性无粉乳胶检查手套，蓝色，经化疗药物、芬太尼盐酸盐、盐酸乙酰胆碱、胃酸、胃酸中的芬太尼和胃酸中的盐酸乙酰胆碱使用测试 K244034一次性无粉乳胶检查手套，蓝色，经化疗药物、芬太尼盐酸盐和盐酸乙酰胆碱使用测试 K220992一次性无粉聚氯乙烯检查手套，黑色/蓝色/紫色 K190403一次性无粉乳胶检查手套，白色，经化疗药物使用测试，一次性无粉乳胶检查手套，蓝色，经化疗药物使用测试

相关器械（代码：LYZ）

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。

K260860无粉合成氯乙烯检查手套（蓝色，黑色）Basic Medical Technology, Inc.K252467一次性乙烯基检查手套Viet Phu Trade and Import Export Co., Ltd.K252505无粉聚氯乙烯检查手套，透明Basic Medical Technology, Inc.K241252一次性乙烯基检查手套Anqing Pukang Medical Technology Co., Ltd.K230046乙烯基检查手套Guangdong Kingfa Sci. & Tech.Co., Ltd.K220992一次性无粉聚氯乙烯检查手套，黑色/蓝色/紫色Ever Global (Vietnam) Enterprise Corporation

官方来源

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