FDA 510(k)

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE

K-Number: K120230 · 2012-07-27

ApplicantShandong Taixiang Medical Products Co., Ltd.

Decision Date2012-07-27

Product CodeLYZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Taixiang Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K120230. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE?

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Shandong Taixiang Medical Products Co., Ltd.. The 510(k) number is K120230.

When did POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE receive FDA 510(k) clearance?

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE received FDA 510(k) clearance on 2012-07-27, under 510(k) number K120230.

Who is the listed applicant for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE?

The FDA 510(k) record lists Shandong Taixiang Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE?

The FDA product code for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE is LYZ.

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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.