FDA 510(k)

OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)

K-Number: K993419 · 1999-11-19

Decision Date1999-11-19

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Omnigrace , Ltd.. It received FDA 510(k) clearance on 1999-11-19 under 510(k) number K993419. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)?

OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 1999-11-19. The listed applicant is Omnigrace , Ltd.. The 510(k) number is K993419.

When did OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) received FDA 510(k) clearance on 1999-11-19, under 510(k) number K993419.

Who is the listed applicant for OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)?

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 OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)?

The FDA product code for OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) is LYY.

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Other records listing Omnigrace , Ltd. as applicant

K994246OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED K993050OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED K991845PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.K991846PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE K983730OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE K983725OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE

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Related Devices (Code: LYY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.