FDA 510(k)

单次使用乳胶无菌手术手套（SG100）

K号: K231446 · 2023-09-22

申请人Fitone Latex Products Co., Ltd. Guangdong

决定日期2023-09-22

产品代码KGO

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决定实质等同

器械摘要

Single-Use Latex Sterile Surgical Gloves (SG100) is the device name listed in this FDA 510(k) record. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231446. 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 Single-Use Latex Sterile Surgical Gloves (SG100)?

Single-Use Latex Sterile Surgical Gloves (SG100) is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K231446.

When did Single-Use Latex Sterile Surgical Gloves (SG100) receive FDA 510(k) clearance?

Single-Use Latex Sterile Surgical Gloves (SG100) received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231446.

Who is the listed applicant for Single-Use Latex Sterile Surgical Gloves (SG100)?

The FDA 510(k) record lists Fitone Latex Products Co., Ltd. Guangdong as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100)?

The FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100) is KGO.

列明Fitone Latex Products Co., Ltd. Guangdong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。

K221747用于化疗药物测试的丁腈患者检查手套 K222693一次性医用乳胶检查手套（LG100）K211927丁腈检查手套

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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