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Found 3 results
510(k) Data Aggregation
K Number
K220055Device Name
Disposable, vinyl examination gloves, Yellow
Manufacturer
Dezhou Hengchang Medical Technology Co., Ltd
Date Cleared
2022-08-25
(231 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dezhou Hengchang Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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K Number
K213634Device Name
Vinyl/Nitrile Blend Exam Glove
Manufacturer
Dezhou Hengchang Medical Technology Co., Ltd.
Date Cleared
2022-02-18
(93 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dezhou Hengchang Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viny/Nitrile Blend Exam 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/nitrile blend 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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K Number
K213625Device Name
Vinyl Examination Gloves
Manufacturer
Dezhou Hengchang Medical Technology Co., Ltd.
Date Cleared
2022-02-17
(92 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dezhou Hengchang Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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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