FDA 510(k) K151208, Powder Free Nitrile Examination Glove, by Vrg Khai Hoan Joint Stock Company
FDA 510(k) K151208, Powder Free Nitrile Examination Glove, by Vrg Khai Hoan Joint Stock Company
Device Classification Name: Polymer Patient Examination Glove
510(k) Number: K151208
Device Name: Powder Free Nitrile Examination Glove
Applicant: Vrg Khai Hoan Joint Stock Company
Regulation Number: 880.6250
Classification Product Code: LZA
Date Received: 05/06/2015
Decision Date: 09/14/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
510k Review Panel: General Hospital
Total number of pages: 214
Fully redacted pages: 119
Content pages: 95
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