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510(k) Data Aggregation
K Number
K212925Device Name
Disposable Surgical Gown
Manufacturer
Date Cleared
2021-12-13
(90 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Henan Robestain Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical gowns met the requirements for Level 3 classification.
Device Description
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile.
There are two types of disposable surgical gown: standard disposable surgical gown, reinforced disposable surgical gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for standard and reinforce disposable surgical gown meet AAMI Level 3.
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