KGO

Surgeon'S Gloves

产品代码
KGO
器械名称
Surgeon'S Gloves
管理类别
第 1 类(Class I)
21 CFR 条款
21 CFR 878.4460
FDA 专业组
General, Plastic Surgery
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
9 件
其中 Summary 已存档
6 份,可直接下载
FDA 历史累计 510(k)
560 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(9 件)

数据窗口为最近三年。最新一件:2026-07-28。

510(k) 号批准日期申请人器械名称摘要
K2605582026-07-28Hartalega NGC Sdn. Bhd.Latex Powder Free Surgical Gloves Tested for Use wit…PDF
K2530602026-05-22Protect Gloves Company LimitedSterile Latex Powder Free Surgical GlovesPDF
K2503132025-08-19Harps Europe Manufacturing GmbHSterile Powder Free Synthetic Rubber Surgeon’s Glove…PDF
K2407902024-08-23Suzhou Colour-Way New Material Co., Lt…Polyisoprene Surgical gloves
K2320792024-03-28Wrp Asia Pacific Sdn. Bhd.Natural Rubber Latex Surgical Glove, Powder Free, St…PDF
K2324442023-12-20Grand Work Plastic Products Co., Ltd.Sterile Powder Free Latex Surgical Gloves, Tested fo…PDF
K2319022023-10-20Ansell HealthcareGAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid…FDA
K2319732023-09-29Ineo Tech Sdn BhdPolyIsoprene Powder Free Black Colour Radiation Atte…FDA
K2314462023-09-22Fitone Latex Products Co., Ltd. Guangd…Single-Use Latex Sterile Surgical Gloves (SG100)PDF

其中 6 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: KGO
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。