Decision Date2012-07-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Northstar Healthcare Holdings. It received FDA 510(k) clearance on 2012-07-12 under 510(k) number K121529. 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 POWDER-FREE EXAMINATION GLOVES?
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2012-07-12. The listed applicant is Northstar Healthcare Holdings. The 510(k) number is K121529.
When did BLACK NITRILE POWDER-FREE EXAMINATION GLOVES receive FDA 510(k) clearance?
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES received FDA 510(k) clearance on 2012-07-12, under 510(k) number K121529.
Who is the listed applicant for BLACK NITRILE POWDER-FREE EXAMINATION GLOVES?
The FDA 510(k) record lists Northstar Healthcare Holdings as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BLACK NITRILE POWDER-FREE EXAMINATION GLOVES?
The FDA product code for BLACK NITRILE POWDER-FREE EXAMINATION GLOVES is LZA.
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Other records listing Northstar Healthcare Holdings as applicant
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K122727BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVEK122788TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 OK123026TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PROK122998BLUE POWDERED NITRILE EXAMINATION GLOVEK121926BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DMK121947ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES View all 9 devices →
Related Devices (Code: 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.