FDA 510(k)

聚异戊二烯无粉，黑色手术手套

K号: K192933 · 2021-01-13

决定日期2021-01-13

产品代码KGO

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Polyisoprene Powder Free, Black Colour Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Emerson & Co. Srl. It received FDA 510(k) clearance on 2021-01-13 under 510(k) number K192933. 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, Black Colour Surgical Gloves?

Polyisoprene Powder Free, Black Colour Surgical Gloves is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Emerson & Co. Srl. The 510(k) number is K192933.

When did Polyisoprene Powder Free, Black Colour Surgical Gloves receive FDA 510(k) clearance?

Polyisoprene Powder Free, Black Colour Surgical Gloves received FDA 510(k) clearance on 2021-01-13, under 510(k) number K192933.

Who is the listed applicant for Polyisoprene Powder Free, Black Colour Surgical Gloves?

The FDA 510(k) record lists Emerson & Co. Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyisoprene Powder Free, Black Colour Surgical Gloves?

The FDA product code for Polyisoprene Powder Free, Black Colour Surgical Gloves is KGO.

列明Emerson & Co. Srl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。

K151228PROGUARD 聚异丁烯无粉，黑色手术手套，型号 1：.22mm 型号 2：.30mm

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。