FDA 510(k)

ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE

K-Number: K063777 · 2007-02-23

Decision Date2007-02-23

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Bright Element Sdn Bhd. It received FDA 510(k) clearance on 2007-02-23 under 510(k) number K063777. 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 ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE?

ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2007-02-23. The listed applicant is Bright Element Sdn Bhd. The 510(k) number is K063777.

When did ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE receive FDA 510(k) clearance?

ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE received FDA 510(k) clearance on 2007-02-23, under 510(k) number K063777.

Who is the listed applicant for ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE?

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

What is the FDA product code for ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE?

The FDA product code for ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE is LZA.

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Other records listing Bright Element Sdn Bhd as applicant

K063776ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES K061074ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES K061078BRIGHT ELEMENT SND BHD LATEX POWDER FREE 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.