FDA 510(k)

无菌乳胶粉无手术手套，无粉

K号: K170515 · 2017-06-09

决定日期2017-06-09

产品代码KGO

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决定实质等同

器械摘要

Sterile Nitrile Surgical Gloves, Powder-free is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K170515. 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 Sterile Nitrile Surgical Gloves, Powder-free?

Sterile Nitrile Surgical Gloves, Powder-free is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K170515.

When did Sterile Nitrile Surgical Gloves, Powder-free receive FDA 510(k) clearance?

Sterile Nitrile Surgical Gloves, Powder-free received FDA 510(k) clearance on 2017-06-09, under 510(k) number K170515.

Who is the listed applicant for Sterile Nitrile Surgical Gloves, Powder-free?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Nitrile Surgical Gloves, Powder-free?

The FDA product code for Sterile Nitrile Surgical Gloves, Powder-free is KGO.

列明Primus Gloves Pvt Limited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。

K170612无菌聚氯乙烯检查手套，无粉 K143477无粉丁腈患者检查手套，蓝色

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.

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