FDA 510(k)

Cardinal Health Protexis PI Blue with Neu-Thera 手术手套

K号: K201592 · 2021-09-26

决定日期2021-09-26

产品代码KGO

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决定实质等同

器械摘要

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K201592. 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 Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K201592.

When did Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove receive FDA 510(k) clearance?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove received FDA 510(k) clearance on 2021-09-26, under 510(k) number K201592.

Who is the listed applicant for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is KGO.

列明Cardinal Health200, LLC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。

K241780Cardinal Health 氮化橡胶检查手套 K230838Cardinal Health™ SmartGown™ EDGE透气手术服，带ASSIST™工具口袋 K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow 控制器，Cardinal Health Element 空气袖，Kendall SCD Express 空气袖，Kendall SCD Express 足部袖，Kendall SCD 顺序压缩舒适袖，Kendall SCD SmartFlow 控制器管路组件 K211390乳胶蓝无粉检查手套 K200824Cardinal Health SMARTGOWN 透气手术服，Cardinal Health SMARTGOWN AIR 透气手术服

查看所有 14 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 Limited K250313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 GmbH K240790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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