FDA 510(k)

PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE

K-Number: K991846 · 1999-08-05

Decision Date1999-08-05

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Omnigrace , Ltd.. It received FDA 510(k) clearance on 1999-08-05 under 510(k) number K991846. 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 PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE?

PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE is a medical device that received FDA 510(k) clearance on 1999-08-05. The listed applicant is Omnigrace , Ltd.. The 510(k) number is K991846.

When did PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE receive FDA 510(k) clearance?

PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE received FDA 510(k) clearance on 1999-08-05, under 510(k) number K991846.

Who is the listed applicant for PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE?

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 PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE?

The FDA product code for PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE is LZA.

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Other records listing Omnigrace , Ltd. as applicant

K994246OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED K993419OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)K993050OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED K991845PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, 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: LZA)

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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.