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FDA 510(k)

VR® Personal Protective Level 3 Gown (VR Gowns)

K-Number: K252940 · 2025-12-16

ApplicantPolyConversions, Inc.
Decision Date2025-12-16
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VR® Personal Protective Level 3 Gown (VR Gowns) is a medical device manufactured by PolyConversions, Inc.. It received FDA 510(k) clearance on 2025-12-16 under approval number K252940. 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 VR® Personal Protective Level 3 Gown (VR Gowns)?

VR® Personal Protective Level 3 Gown (VR Gowns) is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by PolyConversions, Inc.. The 510(k) number is K252940.

When was VR® Personal Protective Level 3 Gown (VR Gowns) approved by the FDA?

VR® Personal Protective Level 3 Gown (VR Gowns) received FDA 510(k) clearance on 2025-12-16, under approval number K252940.

What company makes VR® Personal Protective Level 3 Gown (VR Gowns)?

VR® Personal Protective Level 3 Gown (VR Gowns) is manufactured by PolyConversions, Inc..

What is the FDA product code for VR® Personal Protective Level 3 Gown (VR Gowns)?

The FDA product code for VR® Personal Protective Level 3 Gown (VR Gowns) is QPC.

Related Clinical Trials

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Other Devices by PolyConversions, Inc.

K230384PolyWear® Personal Protective Level 3 Gown

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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