FDA 510(k)

UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES

K-Number: K000689 · 2000-04-28

Decision Date2000-04-28

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is N.S. Uni-Gloves Sdn. Bhd.. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K000689. 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 UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES?

UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is N.S. Uni-Gloves Sdn. Bhd.. The 510(k) number is K000689.

When did UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES receive FDA 510(k) clearance?

UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES received FDA 510(k) clearance on 2000-04-28, under 510(k) number K000689.

Who is the listed applicant for UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES?

The FDA 510(k) record lists N.S. Uni-Gloves Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES?

The FDA product code for UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES is LZA.

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Other records listing N.S. Uni-Gloves Sdn. Bhd. as applicant

K050765LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE K013163UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES K010881UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K010879UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K000688UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES K890965PATIENT EXAMINATION GLOVES

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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.