聚异戊二烯手术手套
K号: K240790 · 2024-08-23
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决定日期2024-08-23
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 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 2024-08-23 under 510(k) number K240790. 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 Surgical gloves?
Polyisoprene Surgical gloves is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. The 510(k) number is K240790.
When did Polyisoprene Surgical gloves receive FDA 510(k) clearance?
Polyisoprene Surgical gloves received FDA 510(k) clearance on 2024-08-23, under 510(k) number K240790.
Who is the listed applicant for Polyisoprene 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 Polyisoprene Surgical gloves?
The FDA product code for Polyisoprene Surgical gloves is KGO.
相关临床试验
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。
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。
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 LimitedK250313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 GmbHK232079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.K231902GAMMEX PI 混合微 (340002055)；GAMMEX PI 混合微 (340002060)；GAMMEX PI 混合微 (340002065)；GAMMEX PI 混合微 (340002070)；GAMMEX PI 混合微 (340002075)；GAMMEX PI 混合微 (340002080)；GAMMEX PI 混合微 (340002085)；GAMMEX PI 混合微 (340002090)Ansell Healthcare
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。
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