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FDA 510(k)

Medline Open-back Level 3 Protective Gown

K-Number: K233526 · 2024-03-05

ApplicantMedline Industries, LP
Decision Date2024-03-05
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Open-back Level 3 Protective Gown is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2024-03-05 under approval number K233526. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Open-back Level 3 Protective Gown?

Medline Open-back Level 3 Protective Gown is a medical device that received FDA 510(k) clearance on 2024-03-05. It is manufactured by Medline Industries, LP. The 510(k) number is K233526.

When was Medline Open-back Level 3 Protective Gown approved by the FDA?

Medline Open-back Level 3 Protective Gown received FDA 510(k) clearance on 2024-03-05, under approval number K233526.

What company makes Medline Open-back Level 3 Protective Gown?

Medline Open-back Level 3 Protective Gown is manufactured by Medline Industries, LP.

What is the FDA product code for Medline Open-back Level 3 Protective Gown?

The FDA product code for Medline Open-back Level 3 Protective Gown is QPC.

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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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