FDA 510(k)

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

K-Number: K000584 · 2000-04-12

ApplicantShasta Asia Partners Gloves Manufacturing CO , Ltd.

Decision Date2000-04-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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 Shasta Asia Partners Gloves Manufacturing CO , Ltd.. It received FDA 510(k) clearance on 2000-04-12 under 510(k) number K000584. 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 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)?

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 2000-04-12. The listed applicant is Shasta Asia Partners Gloves Manufacturing CO , Ltd.. The 510(k) number is K000584.

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

POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) received FDA 510(k) clearance on 2000-04-12, under 510(k) number K000584.

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

The FDA 510(k) record lists Shasta Asia Partners Gloves Manufacturing CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Shasta Asia Partners Gloves Manufacturing CO , Ltd. as applicant

K000670NITRILE EXAM GLOVE, POWDER FREE, BLUE

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.