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FDA 510(k)

HALYARD Flexaprene Green Powder-Free Exam Glove

K-Number: K211063 · 2021-11-19

ApplicantO&M Halyard, Inc.
Decision Date2021-11-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HALYARD Flexaprene Green Powder-Free Exam Glove is a medical device manufactured by O&M Halyard, Inc.. It received FDA 510(k) clearance on 2021-11-19 under approval number K211063. 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 HALYARD Flexaprene Green Powder-Free Exam Glove?

HALYARD Flexaprene Green Powder-Free Exam Glove is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by O&M Halyard, Inc.. The 510(k) number is K211063.

When was HALYARD Flexaprene Green Powder-Free Exam Glove approved by the FDA?

HALYARD Flexaprene Green Powder-Free Exam Glove received FDA 510(k) clearance on 2021-11-19, under approval number K211063.

What company makes HALYARD Flexaprene Green Powder-Free Exam Glove?

HALYARD Flexaprene Green Powder-Free Exam Glove is manufactured by O&M Halyard, Inc..

What is the FDA product code for HALYARD Flexaprene Green Powder-Free Exam Glove?

The FDA product code for HALYARD Flexaprene Green Powder-Free Exam Glove 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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