Search Results
Found 1 results
510(k) Data Aggregation
K Number
K214056Device Name
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
Date Cleared
2022-09-20
(267 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mezorrison Medical Technology (Dongying) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: S, M, L, XL. The subject device is non-sterile.
Ask a Question
Ask a specific question about this device
Page 1 of 1