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510(k) Data Aggregation
K Number
K213851Device Name
Disposable Medical Nitrile gloves
Date Cleared
2022-03-09
(89 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Guangdong Xingcan Brothers Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Medical Nitrile gloves intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Device Description
The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and a rolled rim at the cuff edge.
The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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