Search Results
Found 1 results
510(k) Data Aggregation
K Number
K212551Device Name
Nitrile Examination Gloves
Manufacturer
Date Cleared
2021-11-05
(84 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Fine Glove Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The subject device in this 510(k) Notification is Nitrile Examination Gloves. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
Ask a Question
Ask a specific question about this device
Page 1 of 1