FDA 510(k)

GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

K-Number: K010054 · 2001-01-26

ApplicantGuthrie Medicare Products (Melaka) Sdn Bhd

Decision Date2001-01-26

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Guthrie Medicare Products (Melaka) Sdn Bhd. It received FDA 510(k) clearance on 2001-01-26 under 510(k) number K010054. 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 GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 2001-01-26. The listed applicant is Guthrie Medicare Products (Melaka) Sdn Bhd. The 510(k) number is K010054.

When did GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) received FDA 510(k) clearance on 2001-01-26, under 510(k) number K010054.

Who is the listed applicant for GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

The FDA 510(k) record lists Guthrie Medicare Products (Melaka) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

The FDA product code for GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is LYY.

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Other records listing Guthrie Medicare Products (Melaka) Sdn Bhd as applicant

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Related Devices (Code: LYY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.