Decision Date1999-05-04
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Omnigrace (Thailand) , Ltd.. It received FDA 510(k) clearance on 1999-05-04 under 510(k) number K990695. 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 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE?
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE is a medical device that received FDA 510(k) clearance on 1999-05-04. The listed applicant is Omnigrace (Thailand) , Ltd.. The 510(k) number is K990695.
When did OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE receive FDA 510(k) clearance?
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE received FDA 510(k) clearance on 1999-05-04, under 510(k) number K990695.
Who is the listed applicant for OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE?
The FDA 510(k) record lists Omnigrace (Thailand) , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE?
The FDA product code for OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE is LZA.
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Other records listing Omnigrace (Thailand) , Ltd. as applicant
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K012402OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIMK002922OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)K993479OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)K990698OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLEK990696OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITEK990701OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE View all 12 devices →
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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.