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FDA 510(k)

EMBOSSED DISP. POLY. GLOVES #5101-03

K-Number: K801997 · 1980-09-09

ApplicantPollak (Intl.), Ltd.
Decision Date1980-09-09
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMBOSSED DISP. POLY. GLOVES #5101-03 is the device name listed in this FDA 510(k) record. The listed applicant is Pollak (Intl.), Ltd.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801997. 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 EMBOSSED DISP. POLY. GLOVES #5101-03?

EMBOSSED DISP. POLY. GLOVES #5101-03 is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K801997.

When did EMBOSSED DISP. POLY. GLOVES #5101-03 receive FDA 510(k) clearance?

EMBOSSED DISP. POLY. GLOVES #5101-03 received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801997.

Who is the listed applicant for EMBOSSED DISP. POLY. GLOVES #5101-03?

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

What is the FDA product code for EMBOSSED DISP. POLY. GLOVES #5101-03?

The FDA product code for EMBOSSED DISP. POLY. GLOVES #5101-03 is FMC.

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Other records listing Pollak (Intl.), Ltd. 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.

K000227UMBICUTK810049PEDICAT*K810050VECAFIX*K802011INFUSSION ALARM SYSTEM I.A.S. CAT.#1118K802009FLOWCLAMP CAT.#1011 & 1012K802017DRESSING CHANGE SET CAT.#910-930

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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

View on FDA Database →

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

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