FDA 510(k)

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR

K-Number: K121992 · 2012-10-16

ApplicantXinwei (Shandong) Plastic and Rubber Products Co.,

Decision Date2012-10-16

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Xinwei (Shandong) Plastic and Rubber Products Co.,. It received FDA 510(k) clearance on 2012-10-16 under 510(k) number K121992. 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 PATIENT EXAMINATION GLOVES, BLUE COLOR?

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR is a medical device that received FDA 510(k) clearance on 2012-10-16. The listed applicant is Xinwei (Shandong) Plastic and Rubber Products Co.,. The 510(k) number is K121992.

When did POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR receive FDA 510(k) clearance?

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR received FDA 510(k) clearance on 2012-10-16, under 510(k) number K121992.

Who is the listed applicant for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR?

The FDA 510(k) record lists Xinwei (Shandong) Plastic and Rubber Products Co., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR?

The FDA product code for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR is LZA.

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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.