FDA 510(k)

GUTHRIE PRIME POWDER-FREE

K-Number: K990228 · 1999-02-19

ApplicantGuthrie Medicare Products (Melaka) Sdn Bhd

Decision Date1999-02-19

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

GUTHRIE PRIME POWDER-FREE 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 1999-02-19 under 510(k) number K990228. 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 PRIME POWDER-FREE?

GUTHRIE PRIME POWDER-FREE is a medical device that received FDA 510(k) clearance on 1999-02-19. The listed applicant is Guthrie Medicare Products (Melaka) Sdn Bhd. The 510(k) number is K990228.

When did GUTHRIE PRIME POWDER-FREE receive FDA 510(k) clearance?

GUTHRIE PRIME POWDER-FREE received FDA 510(k) clearance on 1999-02-19, under 510(k) number K990228.

Who is the listed applicant for GUTHRIE PRIME POWDER-FREE?

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 PRIME POWDER-FREE?

The FDA product code for GUTHRIE PRIME POWDER-FREE is LYY.

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

K003922NITRILE EXAMINATION GLOVES (POWERED)K003985POWDERFREE NITRILE PATIENT EXMINATION GLOVE K010078GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)K010054GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K003872GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K001049GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)

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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.