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FDA 510(k)

PATIENT EXAMINATION GLOVE/HYPOALLERGENIC

K-Number: K905109 · 1990-11-21

ApplicantTactyl Technologies, Inc.
Decision Date1990-11-21
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVE/HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Tactyl Technologies, Inc.. It received FDA 510(k) clearance on 1990-11-21 under 510(k) number K905109. 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 PATIENT EXAMINATION GLOVE/HYPOALLERGENIC?

PATIENT EXAMINATION GLOVE/HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1990-11-21. The listed applicant is Tactyl Technologies, Inc.. The 510(k) number is K905109.

When did PATIENT EXAMINATION GLOVE/HYPOALLERGENIC receive FDA 510(k) clearance?

PATIENT EXAMINATION GLOVE/HYPOALLERGENIC received FDA 510(k) clearance on 1990-11-21, under 510(k) number K905109.

Who is the listed applicant for PATIENT EXAMINATION GLOVE/HYPOALLERGENIC?

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

What is the FDA product code for PATIENT EXAMINATION GLOVE/HYPOALLERGENIC?

The FDA product code for PATIENT EXAMINATION GLOVE/HYPOALLERGENIC is FMC.

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Other records listing Tactyl Technologies, Inc. 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.

K955464TACTYLON POWDER FREE EXAMINATION GLOVEK955419POWDER FREE TACTYLON SURGEONS GLOVEK953583LUBRICATED CONDOMK950185TACTYLON(TM) POWDER FREE SURGEONS GLOVEK911431TACTYLON(TM) CONDOMK902831TACTYLON TM SURGICAL GLOVE

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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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