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FDA 510(k)

Latex Examination Powder Free Gloves

K-Number: K211477 · 2021-09-20

ApplicantAspen Glove Sdn. Bhd.
Decision Date2021-09-20
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Latex Examination Powder Free Gloves is a medical device manufactured by Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-09-20 under approval number K211477. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Latex Examination Powder Free Gloves?

Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2021-09-20. It is manufactured by Aspen Glove Sdn. Bhd.. The 510(k) number is K211477.

When was Latex Examination Powder Free Gloves approved by the FDA?

Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2021-09-20, under approval number K211477.

What company makes Latex Examination Powder Free Gloves?

Latex Examination Powder Free Gloves is manufactured by Aspen Glove Sdn. Bhd..

What is the FDA product code for Latex Examination Powder Free Gloves?

The FDA product code for Latex Examination Powder Free Gloves is LYY.

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Other Devices by Aspen Glove Sdn. Bhd.

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Related Devices (Code: LYY)

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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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