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FDA 510(k)

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)

K-Number: K203036 · 2021-05-07

Decision Date2021-05-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is a medical device manufactured by Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under approval number K203036. 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 Polyurethane Examination Gloves (Blue and Black colors)?

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is a medical device that received FDA 510(k) clearance on 2021-05-07. It is manufactured by Central Medicare Sdn Bhd. The 510(k) number is K203036.

When was Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) approved by the FDA?

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) received FDA 510(k) clearance on 2021-05-07, under approval number K203036.

What company makes Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is manufactured by Central Medicare Sdn Bhd.

What is the FDA product code for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?

The FDA product code for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) 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.