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FDA 510(k)

LATEX EXAMINATION GLOVE

K-Number: K882533 · 1988-07-21

ApplicantSukas Export
Decision Date1988-07-21
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Sukas Export. It received FDA 510(k) clearance on 1988-07-21 under 510(k) number K882533. 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 EXAMINATION GLOVE?

LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1988-07-21. The listed applicant is Sukas Export. The 510(k) number is K882533.

When did LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1988-07-21, under 510(k) number K882533.

Who is the listed applicant for LATEX EXAMINATION GLOVE?

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

What is the FDA product code for LATEX EXAMINATION GLOVE?

The FDA product code for LATEX EXAMINATION GLOVE 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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