FDA 510(k)

POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES

K-Number: K092874 · 2010-06-22

Decision Date2010-06-22

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Quality Gallant Sdn. Bhd.. It received FDA 510(k) clearance on 2010-06-22 under 510(k) number K092874. 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 (DARK BLUE) EXAMINATION GLOVES?

POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2010-06-22. The listed applicant is Quality Gallant Sdn. Bhd.. The 510(k) number is K092874.

When did POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES received FDA 510(k) clearance on 2010-06-22, under 510(k) number K092874.

Who is the listed applicant for POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES?

The FDA 510(k) record lists Quality Gallant Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES?

The FDA product code for POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES is LZA.

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Other records listing Quality Gallant Sdn. Bhd. as applicant

K081592POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES K071322POWDER FREE LATEX EXAMINATION GLOVES K071323POWDERED LATEX EXAMINATION GLOVES

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.