FDA 510(k)

POWDER-FREE NITRILE EXAM GLOVE, BLUE

K-Number: K011286 · 2001-05-16

ApplicantNingbo Yujiang Plastic & Rubber Co. , Ltd.

Decision Date2001-05-16

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE NITRILE EXAM GLOVE, BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Yujiang Plastic & Rubber Co. , Ltd.. It received FDA 510(k) clearance on 2001-05-16 under 510(k) number K011286. 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 POWDER-FREE NITRILE EXAM GLOVE, BLUE?

POWDER-FREE NITRILE EXAM GLOVE, BLUE is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Ningbo Yujiang Plastic & Rubber Co. , Ltd.. The 510(k) number is K011286.

When did POWDER-FREE NITRILE EXAM GLOVE, BLUE receive FDA 510(k) clearance?

POWDER-FREE NITRILE EXAM GLOVE, BLUE received FDA 510(k) clearance on 2001-05-16, under 510(k) number K011286.

Who is the listed applicant for POWDER-FREE NITRILE EXAM GLOVE, BLUE?

The FDA 510(k) record lists Ningbo Yujiang Plastic & Rubber Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE NITRILE EXAM GLOVE, BLUE?

The FDA product code for POWDER-FREE NITRILE EXAM GLOVE, BLUE is LZA.

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Other records listing Ningbo Yujiang Plastic & Rubber Co. , Ltd. as applicant

K980677NITRILE EXAM GLOVE, POWDER FREE K964847NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING K894386LATEX EXAMINATION GLOVES

Related Devices (Code: LZA)

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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.