FDA 510(k)

SensiCare PI Ortho LT 外科手套（经化疗药物使用测试）

K号: K203538 · 2021-08-02

决定日期2021-08-02

产品代码KGO

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决定实质等同

器械摘要

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K203538. 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 SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Medline Industries, Inc.. The 510(k) number is K203538.

When did SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-08-02, under 510(k) number K203538.

Who is the listed applicant for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

The FDA product code for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is KGO.

列明Medline Industries, Inc.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。

K230559Hudson RCI® 4 PSI 压力释放阀的 disposable 加湿器（3230），Hudson RCI® 6 PSI 压力释放阀的 disposable 加湿器（3260）K223100Hudson RCI AquaTherm III Plus 外部可调电子加热器（050-14）K222665Medline UNITE® 踝关节融合接骨板系统 K213054Medline Sure-Snap安全注射针，Medline Sure-Snap安全注射器 K212911Konig Mogen 夹 K220565Hudson RCI Triflo II 激励深呼吸训练器

查看所有 74 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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