Decision Date1998-12-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Omnigrace , Ltd.. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K983725. 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, BLUE?
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Omnigrace , Ltd.. The 510(k) number is K983725.
When did OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE receive FDA 510(k) clearance?
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983725.
Who is the listed applicant for OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE?
The FDA 510(k) record lists Omnigrace , 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, BLUE?
The FDA product code for OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE is LZA.
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Other records listing Omnigrace , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K994246OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATEDK993419OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)K993050OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATEDK991845PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.K991846PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILEK983730OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE View all 8 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.