Search Results
Found 1 results
510(k) Data Aggregation
K Number
K120230Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE
Manufacturer
SHANDONG TAIXIANG MEDICAL PRODUCTS CO., LTD.
Date Cleared
2012-07-27
(184 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG TAIXIANG 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
A Powder-Free Vinyl Patient Examination Gloves 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). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. 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.
Ask a Question
Page 1 of 1