FDA 510(k)

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K-Number: K111134 · 2012-01-26

Decision Date2012-01-26

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS is the device name listed in this FDA 510(k) record. The listed applicant is Siem Aempemed Corp., Ltd.. It received FDA 510(k) clearance on 2012-01-26 under 510(k) number K111134. 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 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Siem Aempemed Corp., Ltd.. The 510(k) number is K111134.

When did NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS receive FDA 510(k) clearance?

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS received FDA 510(k) clearance on 2012-01-26, under 510(k) number K111134.

Who is the listed applicant for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

The FDA 510(k) record lists Siem Aempemed Corp., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

The FDA product code for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS is 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.