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FDA 510(k)

Blue Nitrile Examination Glove Powder Free

K-Number: K211479 · 2021-09-16

ApplicantAspen Glove Sdn. Bhd.
Decision Date2021-09-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Blue Nitrile Examination Glove Powder Free is a medical device manufactured by Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-09-16 under approval number K211479. 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 Blue Nitrile Examination Glove Powder Free?

Blue Nitrile Examination Glove Powder Free is a medical device that received FDA 510(k) clearance on 2021-09-16. It is manufactured by Aspen Glove Sdn. Bhd.. The 510(k) number is K211479.

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

Blue Nitrile Examination Glove Powder Free received FDA 510(k) clearance on 2021-09-16, under approval number K211479.

What company makes Blue Nitrile Examination Glove Powder Free?

Blue Nitrile Examination Glove Powder Free is manufactured by Aspen Glove Sdn. Bhd..

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

The FDA product code for Blue Nitrile Examination Glove Powder Free is LZA.

Related Clinical Trials

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Other Devices by Aspen Glove Sdn. Bhd.

K213076AspenMed+ K211477Latex Examination Powder Free Gloves K211478Sterile Latex Surgical Gloves Powder Free

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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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