Search Results
Found 1 results
510(k) Data Aggregation
K Number
K133478Device Name
POWDER FREE POLYETHYLENE EXAMINATION GLOVES
Manufacturer
Date Cleared
2014-06-02
(202 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Polyethylene Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of translucent (clear) Low Density Polyethylene materials and are powder free. The gloves are loose fitting. The physical and performance characteristics of the devices meet all requirements of ASTM standard D-5250-06 (2011) Standard Specification for Poly(vinyl Chloride) Gloves for Medical Application.
Ask a Question
Ask a specific question about this device
Page 1 of 1