FDA 510(k)

BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE

K-Number: K090464 · 2009-04-23

Decision Date2009-04-23

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Pt Mahakarya Inti Buana. It received FDA 510(k) clearance on 2009-04-23 under 510(k) number K090464. 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 BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE?

BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE is a medical device that received FDA 510(k) clearance on 2009-04-23. The listed applicant is Pt Mahakarya Inti Buana. The 510(k) number is K090464.

When did BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE receive FDA 510(k) clearance?

BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE received FDA 510(k) clearance on 2009-04-23, under 510(k) number K090464.

Who is the listed applicant for BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE?

The FDA 510(k) record lists Pt Mahakarya Inti Buana as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE?

The FDA product code for BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE is 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.