Search Results
Found 2 results
510(k) Data Aggregation
K Number
K191092Device Name
Powder-Free Vinyl Patient Examination Gloves, Yellow Color
Manufacturer
Date Cleared
2019-07-22
(89 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Intco Medical Products Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.
Ask a Question
Ask a specific question about this device
K Number
K190095Device Name
Powder-Free Clear Vinyl Patient Examination Gloves
Manufacturer
Date Cleared
2019-06-20
(149 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Intco Medical Products Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners
Device Description
The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
Ask a Question
Ask a specific question about this device
Page 1 of 1