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FDA 510(k)

LATEX EXAM GLOVES, NON-STERILE

K-Number: K882583 · 1988-07-14

ApplicantB Und J Instruments
Decision Date1988-07-14
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAM GLOVES, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is B Und J Instruments. It received FDA 510(k) clearance on 1988-07-14 under 510(k) number K882583. 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 LATEX EXAM GLOVES, NON-STERILE?

LATEX EXAM GLOVES, NON-STERILE is a medical device that received FDA 510(k) clearance on 1988-07-14. The listed applicant is B Und J Instruments. The 510(k) number is K882583.

When did LATEX EXAM GLOVES, NON-STERILE receive FDA 510(k) clearance?

LATEX EXAM GLOVES, NON-STERILE received FDA 510(k) clearance on 1988-07-14, under 510(k) number K882583.

Who is the listed applicant for LATEX EXAM GLOVES, NON-STERILE?

The FDA 510(k) record lists B Und J Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX EXAM GLOVES, NON-STERILE?

The FDA product code for LATEX EXAM GLOVES, NON-STERILE is FMC.

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Related Devices (Code: FMC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., 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.

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