FDA 510(k)

UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K-Number: K010879 · 2001-05-10

Decision Date2001-05-10

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) 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 2001-05-10 under 510(k) number K010879. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)?

UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 2001-05-10. The listed applicant is N.S. Uni-Gloves Sdn. Bhd.. The 510(k) number is K010879.

When did UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) received FDA 510(k) clearance on 2001-05-10, under 510(k) number K010879.

Who is the listed applicant for UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)?

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 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)?

The FDA product code for UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) is LYY.

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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)K000689UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES K000688UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES K890965PATIENT EXAMINATION GLOVES

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Related Devices (Code: LYY)

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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.