Decision Date2013-02-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE 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 2013-02-22 under 510(k) number K122727. 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 BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE?
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Northstar Healthcare Holdings. The 510(k) number is K122727.
When did BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE receive FDA 510(k) clearance?
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE received FDA 510(k) clearance on 2013-02-22, under 510(k) number K122727.
Who is the listed applicant for BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE?
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 BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE?
The FDA product code for BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE is LZA.
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Other records listing Northstar Healthcare Holdings as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K122788TEXTURED, 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 GLOVESK121529BLACK NITRILE POWDER-FREE EXAMINATION GLOVES View all 9 devices →
Related Devices (Code: LZA)
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K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.
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.