FDA 510(k)

Medispo 橡胶外科手套，Medispo 聚异丁烯外科手套

K号: K221748 · 2022-09-13

决定日期2022-09-13

产品代码KGO

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决定实质等同

器械摘要

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Hbm Health Protections, Inc.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K221748. 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 Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Guilin Hbm Health Protections, Inc.. The 510(k) number is K221748.

When did Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves receive FDA 510(k) clearance?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves received FDA 510(k) clearance on 2022-09-13, under 510(k) number K221748.

Who is the listed applicant for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA 510(k) record lists Guilin Hbm Health Protections, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is KGO.

列明Guilin Hbm Health Protections, Inc.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。

K203483Medispo 橡胶外科手套，Medispo 聚异丁烯外科手套

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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