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510(k) Data Aggregation
K Number
K210148Device Name
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
Date Cleared
2022-04-13
(447 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Flosteril Poly-Reinforced Isolation Gowns, Model 8120 (Catalogue Numbers 8120400, 8120430, 8120450, 8120460) is intended to be worn by healthcare personnel to protect patients and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.
Flosteril Poly-Reinforced Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70)
It is a single use, disposable medical device provided non-sterile and not intended for use in operating rooms. The medical device will be available in 15 models in Large, X Large and XX Large sizes.
Device Description
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