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FDA 510(k)

Powder Free Nitrile Examination Gloves, Black

K-Number: K161099 · 2017-02-23

ApplicantPt. Maja Agung Latexindo
Decision Date2017-02-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves, Black is a medical device manufactured by Pt. Maja Agung Latexindo. It received FDA 510(k) clearance on 2017-02-23 under approval number K161099. 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 Examination Gloves, Black?

Powder Free Nitrile Examination Gloves, Black is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Pt. Maja Agung Latexindo. The 510(k) number is K161099.

When was Powder Free Nitrile Examination Gloves, Black approved by the FDA?

Powder Free Nitrile Examination Gloves, Black received FDA 510(k) clearance on 2017-02-23, under approval number K161099.

What company makes Powder Free Nitrile Examination Gloves, Black?

Powder Free Nitrile Examination Gloves, Black is manufactured by Pt. Maja Agung Latexindo.

What is the FDA product code for Powder Free Nitrile Examination Gloves, Black?

The FDA product code for Powder Free Nitrile Examination Gloves, Black is LZA.

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Other Devices by Pt. Maja Agung Latexindo

K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)

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.

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