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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 the device name listed in this FDA 510(k) record. The listed applicant is PolyConversions, Inc.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) 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. The listed applicant is PolyConversions, Inc.. The 510(k) number is K230384.

When did PolyWear® Personal Protective Level 3 Gown receive FDA 510(k) clearance?

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

Who is the listed applicant for PolyWear® Personal Protective Level 3 Gown?

The FDA 510(k) record lists PolyConversions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing PolyConversions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261115VR® Personal Protective Level 4 Gown (VR Gowns)K252940VR® Personal Protective Level 3 Gown (VR Gowns)

Related Devices (Code: QPC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261115VR® Personal Protective Level 4 Gown (VR Gowns)PolyConversions, Inc.K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.K242689AAMI Level 4 Protective; GownAzac GroupK233526Medline Open-back Level 3 Protective GownMedline Industries, LPK222128Protective Gown AAMI Level 4Kenpax International LimitedK212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation

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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