Decision Date2006-03-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NITRILE EXAMINATION GLOVES, POWDERED, 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 2006-03-30 under 510(k) number K053366. 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 NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE?
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE is a medical device that received FDA 510(k) clearance on 2006-03-30. The listed applicant is Pt Mahakarya Inti Buana. The 510(k) number is K053366.
When did NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE receive FDA 510(k) clearance?
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE received FDA 510(k) clearance on 2006-03-30, under 510(k) number K053366.
Who is the listed applicant for NITRILE EXAMINATION GLOVES, POWDERED, 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 NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE?
The FDA product code for NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE is LZA.
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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.