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510(k) K160337

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns by Bam Corporation Limited — Product Code QPC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2017
Date Received
February 8, 2016
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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