510(k) K212464

Dukal Corporation AAMI Level 4 Open-Back Protective Gown by Dukal Corporation — Product Code QPC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 30, 2022
Date Received: August 6, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Device Class: Class II
Regulation Number: 878.4040
Review Panel: HO
Submission Type

A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.

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