FDA 510(k)

灭菌乳胶外科手套

K号: K222620 · 2023-03-23

申请人Suzhou Colour-Way New Material Co., Ltd.

决定日期2023-03-23

产品代码KGO

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决定实质等同

器械摘要

Sterilized Latex Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222620. 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 Sterilized Latex Surgical Gloves?

Sterilized Latex Surgical Gloves is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. The 510(k) number is K222620.

When did Sterilized Latex Surgical Gloves receive FDA 510(k) clearance?

Sterilized Latex Surgical Gloves received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222620.

Who is the listed applicant for Sterilized Latex Surgical Gloves?

The FDA 510(k) record lists Suzhou Colour-Way New Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilized Latex Surgical Gloves?

The FDA product code for Sterilized Latex Surgical Gloves is KGO.

列明Suzhou Colour-Way New Material 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。

K240790聚异戊二烯手术手套 K222611男性乳胶避孕套

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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