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510(k) Data Aggregation
K Number
K213832Device Name
AAMI3 Isolation Gown
Manufacturer
Date Cleared
2022-05-16
(158 days)
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hubei Xinxin Non-woven Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Isolation Gown, Model 4005 and 4022, is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not in the operating room. In addition, the Isolation Gown, Model 4005 and 4022 meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gown, Model 4005 and 4022, is a single use, disposable medical device provided non-sterile.
Protective Gown, Model 4021, is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. The Protective Gown, Model 4021, is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
Device Description
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