SBG Black Nitrile Powder Free Medical Examination Glove
K-Number: K180468 · 2018-10-10
ApplicantShowa Best Glove, Inc.
Decision Date2018-10-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SBG Black Nitrile Powder Free Medical Examination Glove is a medical device manufactured by Showa Best Glove, Inc.. It received FDA 510(k) clearance on 2018-10-10 under approval number K180468. 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 SBG Black Nitrile Powder Free Medical Examination Glove?
SBG Black Nitrile Powder Free Medical Examination Glove is a medical device that received FDA 510(k) clearance on 2018-10-10. It is manufactured by Showa Best Glove, Inc.. The 510(k) number is K180468.
When was SBG Black Nitrile Powder Free Medical Examination Glove approved by the FDA?
SBG Black Nitrile Powder Free Medical Examination Glove received FDA 510(k) clearance on 2018-10-10, under approval number K180468.
What company makes SBG Black Nitrile Powder Free Medical Examination Glove?
SBG Black Nitrile Powder Free Medical Examination Glove is manufactured by Showa Best Glove, Inc..
What is the FDA product code for SBG Black Nitrile Powder Free Medical Examination Glove?
The FDA product code for SBG Black Nitrile Powder Free Medical Examination Glove 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.