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510(k) Data Aggregation
K Number
K220469Device Name
Disposable Vinyl Examination Glove
Manufacturer
Chifeng Huawei Medical Science&Technology Co.,Ltd.
Date Cleared
2022-06-16
(118 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Chifeng Huawei Medical Science&Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DISPOSABLE VINYL EXAMINATION GLOVE is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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K Number
K212833Device Name
Disposable Nitrile Examination Gloves
Manufacturer
Chifeng Huawei Medical Science & Technology Co., Ltd
Date Cleared
2022-02-28
(174 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Chifeng Huawei Medical Science & Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Nitrile Examination Gloves is 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 subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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