FDA 510(k)

BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA

K-Number: K992337 · 1999-08-17

Decision Date1999-08-17

Product CodeFMC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA is the device name listed in this FDA 510(k) record. The listed applicant is Mexpo Intl., Inc.. It received FDA 510(k) clearance on 1999-08-17 under 510(k) number K992337. 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 BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA?

BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA is a medical device that received FDA 510(k) clearance on 1999-08-17. The listed applicant is Mexpo Intl., Inc.. The 510(k) number is K992337.

When did BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA receive FDA 510(k) clearance?

BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA received FDA 510(k) clearance on 1999-08-17, under 510(k) number K992337.

Who is the listed applicant for BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA?

The FDA 510(k) record lists Mexpo Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA?

The FDA product code for BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA is FMC.

Related Clinical Trials

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Other records listing Mexpo Intl., Inc. as applicant

K990210POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP K984040BLOSSOM POWDERED LATEX EXAMINATION GLOVES K974782LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES

Related Devices (Code: FMC)

K042618LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)La Glove (M) Sdn. Bhd.K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.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

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