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FDA计划对有粉医用手套和手套粉采取禁令
发布时间:2016-03-23
 

更新日期:2016-03-23

 

来源:FDA

 

FDA计划对有粉医用手套和手套粉采取禁令

 

IRC 2016323讯,FDA2016322发布公告,计划对以下三种有粉手套采取禁令:

 

CFR

Product Code

Common Name

21 CFR 880.6250

FMC

Non-Natural Rubber Latex, Powdered,

Patient Examination Glove

有粉患者检查手套

21 CFR 878.4460

KGO

NR Latex,Powdered, Surgeon’s gloves

有粉外科手套

21 CFR 878.4460

OPG

Non-NR Latex, Powdered, Surgeon’s gloves

有粉外科手套

21 CFR 878.4480

KGP

Surgeon’s Glove Powder

用于润滑外科手套的可吸收粉末

 

当前为征询期,2016620结束问询并将最终发布该法令。该禁令基于部分有粉手套使用的粉末已经被证实会导致严重的人身伤害,风险包括呼吸道过敏反应,肺部炎症,手术后粘连和死亡。 FDA已经确定,使用这些手套和手套粉末是危险的,并无法通过全新或更新的标签来减低该风险。

 

https://www.federalregister.gov/articles/2016/03/22/2016-06360/banned-devices-proposal-to-ban-powdered-surgeons-gloves-powdered-patient-examination-gloves-and?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

On March 22, 2016, the FDA announced a proposal to ban powdered surgeons gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeons gloves. For more information about the proposed ban, please see the Federal Register.

 

While medical gloves play a significant role in protecting patients, health care providers and other individuals in close proximity, the powder used on some gloves has been proven to cause serious injury. Risks include respiratory allergic reactions, lung inflammation, post-surgical adhesions and possibly death. The FDA has determined that use of these gloves and glove powder is dangerous and presents unreasonable and substantial risk that cannot be corrected through new or updated labeling.

 

Comments to the proposed rule can be submitted to the docket until June 20, 2016.

 

 

IRC编译整理

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