FDA 510(k)

GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES

K-Number: K954967 · 1996-04-15

ApplicantGuthrie Medicare Products (Melaka) Sdn Bhd

Decision Date1996-04-15

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES 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 1996-04-15 under 510(k) number K954967. 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 POWDERFREE LATEX EXAMINATION GLOVES?

GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Guthrie Medicare Products (Melaka) Sdn Bhd. The 510(k) number is K954967.

When did GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 1996-04-15, under 510(k) number K954967.

Who is the listed applicant for GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES?

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 POWDERFREE LATEX EXAMINATION GLOVES?

The FDA product code for GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES 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)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.