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510(k) Data Aggregation
K Number
K212422Device Name
Disposable Surgical Isolation Gown
Manufacturer
Date Cleared
2022-04-29
(268 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Crown Name Disposable Hygiene Products Fty.Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
Device Description
The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. 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 isolation gown meet the requirements for Level 4 classification.
The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
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