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510(k) Data Aggregation
K Number
K212717Device Name
Paneffort AAMI Level 3 Isolation Gown
Manufacturer
Paneffort, LLC
Date Cleared
2022-11-30
(460 days)
Product Code
FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Paneffort, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAM Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
Device Description
The Paneffort AAMI Level 3 Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. The Paneffort AAMI Level 3 Isolation Gown is a single use, disposable medical device provided non-sterile. Paneffort AAMI Level 3 Isolation Gown is offered in one color (blue) and six different sizes of Small, Medium, Regular/Large, X-Large, 2X-Large, and 3X-Large. Each model is constructed of a nonwoven Spunbond-Meltblown-Spunbond (SMS) material that is tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
The Paneffort AAMI Level 3 Isolation Gown consists of one critical zone throughout the entire gown including seams, but excluding cuffs, hems, and bindings as per AAMI PB70:2012. It is a protective tape sealed gown along with other design features like tieneck, elastic cuffs, and belt tie, that meets AAMI PB70 Level 3 barrier performance for protective apparel.
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K Number
K221409Device Name
Paneffort 3-ply Surgical and Procedural Masks
Manufacturer
Paneffort, LLC
Date Cleared
2022-07-25
(70 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Paneffort, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Paneffort 3-ply Surgical and Procedural Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Device Description
The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on. Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later. Paneffort 3-ply Surgical and Procedural masks are available in blue colour.
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