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510(k) Data Aggregation
K Number
K212436Device Name
NBR Synthetic Nitrile Examination Gloves
Manufacturer
Date Cleared
2021-12-23
(141 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shandong Langtai International Trade 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 examiner's hands to prevent contamination between patient and examiner.
Device Description
The subject device is powder free vinyl examination gloves, adding 1%-3% nitrile to improve the tensile strength and ultimate elongation. The subject device is blue color. lt can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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