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FDA 510(k)

PolyWear® Personal Protective Level 3 Gown

K-Number: K230384 · 2023-08-11

ApplicantPolyConversions, Inc.
Decision Date2023-08-11
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PolyWear® Personal Protective Level 3 Gown is a medical device manufactured by PolyConversions, Inc.. It received FDA 510(k) clearance on 2023-08-11 under approval number K230384. 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 PolyWear® Personal Protective Level 3 Gown?

PolyWear® Personal Protective Level 3 Gown is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by PolyConversions, Inc.. The 510(k) number is K230384.

When was PolyWear® Personal Protective Level 3 Gown approved by the FDA?

PolyWear® Personal Protective Level 3 Gown received FDA 510(k) clearance on 2023-08-11, under approval number K230384.

What company makes PolyWear® Personal Protective Level 3 Gown?

PolyWear® Personal Protective Level 3 Gown is manufactured by PolyConversions, Inc..

What is the FDA product code for PolyWear® Personal Protective Level 3 Gown?

The FDA product code for PolyWear® Personal Protective Level 3 Gown is QPC.

Related Clinical Trials

NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT06671171 Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial COMPLETED

Other Devices by PolyConversions, Inc.

K252940VR® Personal Protective Level 3 Gown (VR Gowns)

Related Devices (Code: 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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