FDA 510(k)

LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)

K-Number: K042618 · 2004-11-26

Decision Date2004-11-26

Product CodeFMC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) is the device name listed in this FDA 510(k) record. The listed applicant is La Glove (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2004-11-26 under 510(k) number K042618. The device is classified under product code FMC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)?

LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) is a medical device that received FDA 510(k) clearance on 2004-11-26. The listed applicant is La Glove (M) Sdn. Bhd.. The 510(k) number is K042618.

When did LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) receive FDA 510(k) clearance?

LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) received FDA 510(k) clearance on 2004-11-26, under 510(k) number K042618.

Who is the listed applicant for LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)?

The FDA 510(k) record lists La Glove (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)?

The FDA product code for LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) is FMC.

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Other records listing La Glove (M) Sdn. Bhd. as applicant

K093335LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)K093193LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)K092498LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)K092499LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)K010863LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)K010860LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)

View all 22 devices →

Related Devices (Code: FMC)

K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.K920649COMPASEPWilde-USA, Inc.

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.