FDA 510(k)

FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM

K-Number: K000813 · 2000-06-08

ApplicantAllegiance Healthcare Coporation

Decision Date2000-06-08

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Coporation. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K000813. 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 FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM?

FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Allegiance Healthcare Coporation. The 510(k) number is K000813.

When did FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM receive FDA 510(k) clearance?

FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM received FDA 510(k) clearance on 2000-06-08, under 510(k) number K000813.

Who is the listed applicant for FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM?

The FDA 510(k) record lists Allegiance Healthcare Coporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM?

The FDA product code for FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM is LZA.

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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.