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FDA 510(k)

Nitrile Patient Examination Powder Free Glove, Textured, Black

K-Number: K161085 · 2018-07-05

ApplicantMultisafe Sdn. Bhd.
Decision Date2018-07-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Patient Examination Powder Free Glove, Textured, Black is a medical device manufactured by Multisafe Sdn. Bhd.. It received FDA 510(k) clearance on 2018-07-05 under approval number K161085. 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 Nitrile Patient Examination Powder Free Glove, Textured, Black?

Nitrile Patient Examination Powder Free Glove, Textured, Black is a medical device that received FDA 510(k) clearance on 2018-07-05. It is manufactured by Multisafe Sdn. Bhd.. The 510(k) number is K161085.

When was Nitrile Patient Examination Powder Free Glove, Textured, Black approved by the FDA?

Nitrile Patient Examination Powder Free Glove, Textured, Black received FDA 510(k) clearance on 2018-07-05, under approval number K161085.

What company makes Nitrile Patient Examination Powder Free Glove, Textured, Black?

Nitrile Patient Examination Powder Free Glove, Textured, Black is manufactured by Multisafe Sdn. Bhd..

What is the FDA product code for Nitrile Patient Examination Powder Free Glove, Textured, Black?

The FDA product code for Nitrile Patient Examination Powder Free Glove, Textured, Black is LZA.

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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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