Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
K-Number: K200539 · 2020-04-09
Decision Date2020-04-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is a medical device manufactured by Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2020-04-09 under approval number K200539. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K200539.
When was Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl approved by the FDA?
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2020-04-09, under approval number K200539.
What company makes Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is manufactured by Sri Trang Gloves (Thailand) Public Company Limited.
What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?
The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is LZA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.