FDA 510(k)

POLYISOPRENE 无粉手术手套，POLYISOPRENE 无粉手术手套

K号: K161008 · 2016-07-28

决定日期2016-07-28

产品代码KGO

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决定实质等同

器械摘要

POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161008. 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 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE?

POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K161008.

When did POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE receive FDA 510(k) clearance?

POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161008.

Who is the listed applicant for POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE?

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

What is the FDA product code for POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE?

The FDA product code for POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE is KGO.

列明Hartalega 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。

K201748天然乳胶无粉手术手套，每克手套蛋白质标注50微克或更少，并经过化疗药物使用测试 K201531无菌乳胶粉无检查手套，用于化疗药物和芬太尼盐酸盐（蓝色）K200897用于化疗药物的聚异戊二烯无粉手术手套（蓝色），用于化疗药物的自然色聚异戊二烯无粉手术手套 K180645无菌无粉检查手套，含有USP胶状燕麦和经测试可用于化疗药物 - （柠檬绿色）K180786无菌乳胶粉无检查手套，用于化疗药物测试，水蓝色（ABLU），无菌乳胶粉无检查手套，用于化疗药物测试，紫蓝色（VBLU） - 延长袖 K173509可降解乳胶检查手套，无粉，蓝色

查看所有 17 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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