FDA 510(k)

BLACK NITRILE EXAMINATION GLOVES

K-Number: K083908 · 2009-03-06

Decision Date2009-03-06

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BLACK NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Gloves Co;, Ltd.. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K083908. 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?

BLACK NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is Innovative Gloves Co;, Ltd.. The 510(k) number is K083908.

When did BLACK NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

BLACK NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 2009-03-06, under 510(k) number K083908.

Who is the listed applicant for BLACK NITRILE EXAMINATION GLOVES?

The FDA 510(k) record lists Innovative Gloves Co;, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLACK NITRILE EXAMINATION GLOVES?

The FDA product code for BLACK NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Innovative Gloves Co;, Ltd. as applicant

K111158LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)K103670NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)K021668NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)K013333LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM K993567INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]K993325INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE

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Related Devices (Code: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.