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FDA 510(k)

Betel Gloves Nitrile Examination Glove Powder Free

K-Number: K222342 · 2022-09-24

ApplicantBetel Care Sdn. Bhd.
Decision Date2022-09-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Betel Gloves Nitrile Examination Glove Powder Free is a medical device manufactured by Betel Care Sdn. Bhd.. It received FDA 510(k) clearance on 2022-09-24 under approval number K222342. 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 Betel Gloves Nitrile Examination Glove Powder Free?

Betel Gloves Nitrile Examination Glove Powder Free is a medical device that received FDA 510(k) clearance on 2022-09-24. It is manufactured by Betel Care Sdn. Bhd.. The 510(k) number is K222342.

When was Betel Gloves Nitrile Examination Glove Powder Free approved by the FDA?

Betel Gloves Nitrile Examination Glove Powder Free received FDA 510(k) clearance on 2022-09-24, under approval number K222342.

What company makes Betel Gloves Nitrile Examination Glove Powder Free?

Betel Gloves Nitrile Examination Glove Powder Free is manufactured by Betel Care Sdn. Bhd..

What is the FDA product code for Betel Gloves Nitrile Examination Glove Powder Free?

The FDA product code for Betel Gloves Nitrile Examination Glove Powder Free 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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