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FDA 510(k)

GLOVES, PROCEDURE

K-Number: K781278 · 1978-08-31

ApplicantArbrook Mfg. Corp.
Decision Date1978-08-31
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVES, PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Arbrook Mfg. Corp.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781278. 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 GLOVES, PROCEDURE?

GLOVES, PROCEDURE is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Arbrook Mfg. Corp.. The 510(k) number is K781278.

When did GLOVES, PROCEDURE receive FDA 510(k) clearance?

GLOVES, PROCEDURE received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781278.

Who is the listed applicant for GLOVES, PROCEDURE?

The FDA 510(k) record lists Arbrook Mfg. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVES, PROCEDURE?

The FDA product code for GLOVES, PROCEDURE is FMC.

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Other records listing Arbrook Mfg. Corp. as applicant

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.

K792016DISCARD-A-PAD 40-COUNT SHARPS DISPOSALK781847LATEX, IN-HOUSE COMPOUNDEDK770056GLOVES, SURGEONS,MICRO-TOUCH POWDERFREEK760421THERMOMETER, SURVALENT-ELECTRONIC

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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