FDA 510(k)

GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)

K-Number: K001047 · 2000-04-28

ApplicantGuthrie Medicare Products (Melaka) Sdn Bhd

Decision Date2000-04-28

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) 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 2000-04-28 under 510(k) number K001047. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)?

GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Guthrie Medicare Products (Melaka) Sdn Bhd. The 510(k) number is K001047.

When did GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) receive FDA 510(k) clearance?

GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) received FDA 510(k) clearance on 2000-04-28, under 510(k) number K001047.

Who is the listed applicant for GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)?

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 LATEX SURGICAL GLOVE (PRE-POWDERED)?

The FDA product code for GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) is KGO.

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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: KGO)

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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.