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510(k) Data Aggregation
K Number
K212009Device Name
Disposable Nitrile Gloves
Manufacturer
Date Cleared
2021-09-15
(79 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Shenglijie Safety Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
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