FDA 510(k)

无菌聚异丁烯粉无手术手套，用于化疗药物测试

K号: K171898 · 2017-08-18

申请人Better Care Plastic Technology Co., Ltd.

决定日期2017-08-18

产品代码KGO

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决定实质等同

器械摘要

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171898. 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 Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs?

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Better Care Plastic Technology Co., Ltd.. The 510(k) number is K171898.

When did Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs receive FDA 510(k) clearance?

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171898.

Who is the listed applicant for Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs?

The FDA 510(k) record lists Better Care Plastic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is KGO.

列明Better Care Plastic Technology Co., Ltd.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。

K242533无粉乳胶患者检查手套，蓝色，非无菌，低皮炎潜力。经过与化疗药物和芬太尼使用的测试 K232266无粉乳胶患者检查手套，蓝色，非无菌，经过与化疗药物和芬太尼使用的测试 K232070用于与化疗药物和芬太尼盐酸盐（黑色，绿色）使用的可降解乳胶检查手套 K231567用于与化疗药物、芬太尼盐酸盐和选定的其他药物使用的可降解乳胶检查手套，无粉（蓝色）K223713无菌无粉丁腈检查手套（灰色）经测试可用于化疗药物和芬太尼柠檬酸盐 K222449丁腈粉末无粉检查手套，经测试可用于化疗药物和芬太尼盐酸盐（深蓝色）

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 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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