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FDA 510(k)

Ivory Glove Powder-Free Nitrile Examination Gloves

K-Number: K213681 · 2022-04-21

ApplicantIvory Gloves Sdn. Bhd.
Decision Date2022-04-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ivory Glove Powder-Free Nitrile Examination Gloves is a medical device manufactured by Ivory Gloves Sdn. Bhd.. It received FDA 510(k) clearance on 2022-04-21 under approval number K213681. 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 Ivory Glove Powder-Free Nitrile Examination Gloves?

Ivory Glove Powder-Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-04-21. It is manufactured by Ivory Gloves Sdn. Bhd.. The 510(k) number is K213681.

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

Ivory Glove Powder-Free Nitrile Examination Gloves received FDA 510(k) clearance on 2022-04-21, under approval number K213681.

What company makes Ivory Glove Powder-Free Nitrile Examination Gloves?

Ivory Glove Powder-Free Nitrile Examination Gloves is manufactured by Ivory Gloves Sdn. Bhd..

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

The FDA product code for Ivory Glove Powder-Free Nitrile Examination Gloves 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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