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FDA 510(k)

FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)

K-Number: K043149 · 2005-05-25

Decision Date2005-05-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) is the device name listed in this FDA 510(k) record. The listed applicant is Firstline, LLC. It received FDA 510(k) clearance on 2005-05-25 under 510(k) number K043149. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)?

FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) is a medical device that received FDA 510(k) clearance on 2005-05-25. The listed applicant is Firstline, LLC. The 510(k) number is K043149.

When did FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) receive FDA 510(k) clearance?

FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) received FDA 510(k) clearance on 2005-05-25, under 510(k) number K043149.

Who is the listed applicant for FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)?

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

What is the FDA product code for FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)?

The FDA product code for FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) is LZA.

Related Clinical Trials

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.

Related Devices (Code: LZA)

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.

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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