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FDA 510(k)

GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM

K-Number: K040448 · 2004-03-23

ApplicantRosner-Mautby Meditrade(Thailand) , Ltd.
Decision Date2004-03-23
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Rosner-Mautby Meditrade(Thailand) , Ltd.. It received FDA 510(k) clearance on 2004-03-23 under 510(k) number K040448. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM?

GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM is a medical device that received FDA 510(k) clearance on 2004-03-23. The listed applicant is Rosner-Mautby Meditrade(Thailand) , Ltd.. The 510(k) number is K040448.

When did GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM receive FDA 510(k) clearance?

GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM received FDA 510(k) clearance on 2004-03-23, under 510(k) number K040448.

Who is the listed applicant for GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM?

The FDA 510(k) record lists Rosner-Mautby Meditrade(Thailand) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM?

The FDA product code for GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM is LYY.

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Related Devices (Code: LYY)

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.

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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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