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FDA 510(k)

无菌乳胶粉无手术手套

K号: K222350 · 2023-04-13

申请人Jr Engineering & Medical Technologies (M) Sdn. Bhd.
决定日期2023-04-13
产品代码KGO
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Sterile Nitrile Surgical Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K222350. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sterile Nitrile Surgical Gloves Powder Free?

Sterile Nitrile Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K222350.

When did Sterile Nitrile Surgical Gloves Powder Free receive FDA 510(k) clearance?

Sterile Nitrile Surgical Gloves Powder Free received FDA 510(k) clearance on 2023-04-13, under 510(k) number K222350.

Who is the listed applicant for Sterile Nitrile Surgical Gloves Powder Free?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Nitrile Surgical Gloves Powder Free?

The FDA product code for Sterile Nitrile Surgical Gloves Powder Free is KGO.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Jr Engineering & Medical Technologies (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。

K221626Jr Medic 蓝色丁腈检查手套（无粉），用于化疗药物和芬太尼盐酸盐测试K222348JR MEDICK221169JR MEDIC 乳胶检查手套无粉-黑色K222349JR MEDIC 乳胶检查手套无粉（橙色，紫色）K221157JR MedicK212827Jr Medic 蓝色丁腈检查手套（无粉），用于化疗药物测试

查看所有 10 个设备 →

相关器械（代码：KGO）

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。

K260558无粉乳胶外科手套，适用于化疗药物和芬太尼盐酸盐的使用测试；含胶体燕麦的无粉乳胶外科手套，适用于化疗药物和芬太尼盐酸盐的使用测试Hartalega NGC Sdn. Bhd.K253060无菌乳胶无粉手术手套Protect Gloves Company LimitedK250313无菌无粉合成橡胶外科手套，绿色，经测试可用于化疗药物和胃酸Harps Europe Manufacturing GmbHK240790聚异戊二烯手术手套Suzhou Colour-Way New Material Co., Ltd.K232079天然橡胶乳胶外科手套，无粉，无菌，经化疗药物和芬太尼使用测试（绿色）；天然橡胶乳胶（条状/涂层）/（条状/包装）外科手套，无粉，无菌，经化疗药物和芬太尼使用测试Wrp Asia Pacific Sdn. Bhd.K232444无菌粉无乳胶手术手套，用于化疗药物测试Grand Work Plastic Products Co., Ltd.

官方来源

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