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510(k) Data Aggregation
K Number
K241252Device Name
Disposable Vinyl Examination Gloves
Manufacturer
Anqing Pukang Medical Technology Co., LTD.
Date Cleared
2024-05-20
(17 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Product Code :
LYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Vinyl Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5
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K Number
K230046Device Name
Vinyl examination gloves
Manufacturer
Guangdong Kingfa Sci.& Tech.Co., Ltd.
Date Cleared
2023-03-25
(78 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Product Code :
LYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Device Description
The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.
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K Number
K221980Device Name
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
Manufacturer
Ever Global (Vietnam) Enterprise Corporation
Date Cleared
2023-02-06
(216 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Product Code :
LYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
A Disposable Powder Free Vinyl Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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K Number
K220992Device Name
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
Manufacturer
Ever Global (Vietnam) Enterprise Corporation
Date Cleared
2022-10-19
(198 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Product Code :
LYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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K Number
K223008Device Name
Disposable Vinyl Examination Gloves
Manufacturer
Jiangxi Handspro Products Solutions CO., LTD.
Date Cleared
2022-10-08
(9 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Product Code :
LYZ
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 non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
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K Number
K222442Device Name
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
Manufacturer
Anhui Bytech Medical Supplies Co., Ltd.
Date Cleared
2022-09-28
(47 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Product Code :
LYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) 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 glove. The subject device's color is pink, black and 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
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?
Product Code :
LYZ
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
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?
Product Code :
LYZ
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
K220240Device Name
Vinyl Co-Polymer Powder-free Examination Gloves, Black
Manufacturer
Grand Work Plastic Products Co., Ltd
Date Cleared
2022-03-31
(62 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Product Code :
LYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Vinyl Co-Polymer Powder-free Examination Gloves, Black are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.
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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?
Product Code :
LYZ
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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