FDA 510(k) Applications Submitted by Smart Glove Corporation Sdn.Bhd.

FDA 510(k) Number Submission Date Device Name Applicant
K181047 04/19/2018 Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd.
K213373 10/12/2021 Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Smart Glove Corporation Sdn.Bhd.


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