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FDA 510(k)

POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES

K-Number: K121811 · 2012-11-21

ApplicantShen Wei (Usa), Inc.
Decision Date2012-11-21
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei (Usa), Inc.. It received FDA 510(k) clearance on 2012-11-21 under 510(k) number K121811. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES?

POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES is a medical device that received FDA 510(k) clearance on 2012-11-21. The listed applicant is Shen Wei (Usa), Inc.. The 510(k) number is K121811.

When did POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES receive FDA 510(k) clearance?

POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES received FDA 510(k) clearance on 2012-11-21, under 510(k) number K121811.

Who is the listed applicant for POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES?

The FDA 510(k) record lists Shen Wei (Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES?

The FDA product code for POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES is LZC.

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Related Devices (Code: LZC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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