FDA 510(k)

ENCORE Latex Textured Surgical Gloves，无粉，带有蛋白质含量标签声明（50微克或更少）并经过化疗药物使用测试

K号: K202765 · 2021-05-27

决定日期2021-05-27

产品代码KGO

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决定实质等同

器械摘要

ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs is the device name listed in this FDA 510(k) record. The listed applicant is Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-05-27 under 510(k) number K202765. 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 ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs?

ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs is a medical device that received FDA 510(k) clearance on 2021-05-27. The listed applicant is Careplus (M) Sdn Bhd. The 510(k) number is K202765.

When did ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs receive FDA 510(k) clearance?

ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs received FDA 510(k) clearance on 2021-05-27, under 510(k) number K202765.

Who is the listed applicant for ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs?

The FDA 510(k) record lists Careplus (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs?

The FDA product code for ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs is KGO.

列明Careplus (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。

K211621天然乳胶外科手套，无粉，蛋白质含量标注（50微克或更少）K203705天然乳胶检查手套，无粉，蛋白质含量标注（每克总可提取物蛋白质50ug或更少）K201857无粉乳胶检查手套黑色和双色白-蓝 K210724ENCORE Latex Acclaim，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套50ug/dm2的总水溶性蛋白）并经过化疗药物使用测试，GAMMEX Latex Standard，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套50ug/dm2的总水溶性蛋白）并经过化疗药物使用测试 K210656ENCORE Latex Ortho，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套<50µg/dm2的总水溶性蛋白）并经过化疗药物使用测试，GAMMEX Latex Ortho，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套<50 µg/dm2的总水溶性蛋白）并经过化疗药物使用测试 K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

查看所有 8 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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