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FDA 510(k)

Medline Orbis Chemo Surgical Gown

K-Number: K214108 · 2022-05-06

ApplicantMedline Industries, LP
Decision Date2022-05-06
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Orbis Chemo Surgical Gown is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2022-05-06 under approval number K214108. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Orbis Chemo Surgical Gown?

Medline Orbis Chemo Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Medline Industries, LP. The 510(k) number is K214108.

When was Medline Orbis Chemo Surgical Gown approved by the FDA?

Medline Orbis Chemo Surgical Gown received FDA 510(k) clearance on 2022-05-06, under approval number K214108.

What company makes Medline Orbis Chemo Surgical Gown?

Medline Orbis Chemo Surgical Gown is manufactured by Medline Industries, LP.

What is the FDA product code for Medline Orbis Chemo Surgical Gown?

The FDA product code for Medline Orbis Chemo Surgical Gown is FYA.

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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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