Decision Date2005-09-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Pt.Shamrock Manufacturing Corp.. It received FDA 510(k) clearance on 2005-09-15 under 510(k) number K052382. 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 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE is a medical device that received FDA 510(k) clearance on 2005-09-15. The listed applicant is Pt.Shamrock Manufacturing Corp.. The 510(k) number is K052382.
When did POWDER FREE NITRILE EXAMINATION GLOVES, BLUE receive FDA 510(k) clearance?
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE received FDA 510(k) clearance on 2005-09-15, under 510(k) number K052382.
Who is the listed applicant for POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?
The FDA 510(k) record lists Pt.Shamrock Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?
The FDA product code for POWDER FREE NITRILE EXAMINATION GLOVES, BLUE 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.