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510(k) Data Aggregation
K Number
K102593Device Name
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION
Manufacturer
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
Date Cleared
2010-12-20
(102 days)
Product Code
LYZ, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250. Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.
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K Number
K100294Device Name
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
Date Cleared
2010-05-14
(101 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored
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K Number
K100486Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Manufacturer
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
Date Cleared
2010-05-05
(75 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
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