FDA 510(k)

UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES

K-Number: K000688 · 2000-04-12

Decision Date2000-04-12

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

UNIGLOVE NITRILE POWDERED 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 2000-04-12 under 510(k) number K000688. 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 POWDERED EXAMINATION GLOVES?

UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2000-04-12. The listed applicant is N.S. Uni-Gloves Sdn. Bhd.. The 510(k) number is K000688.

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

UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES received FDA 510(k) clearance on 2000-04-12, under 510(k) number K000688.

Who is the listed applicant for UNIGLOVE NITRILE POWDERED 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 POWDERED EXAMINATION GLOVES?

The FDA product code for UNIGLOVE NITRILE POWDERED 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)K000689UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES K890965PATIENT EXAMINATION GLOVES

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Related Devices (Code: LZA)

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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.