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510(k) Data Aggregation
K Number
K212633Device Name
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
Manufacturer
Date Cleared
2021-11-24
(97 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
String King Lacrosse, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets 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). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.
Device Description
Disposable, single-use isolation gown. The StringKing Disposable Isolation Gown is made of blue polyethylene and serves as a barrier to the transfer of microorganisms, body fluids and particulate material. The gowns feature hook and loop neck closure with a strap for fastening the back of the gown. The gown sleeves have thumb-loops to keep sleeves from sliding when donning the gown. The gowns are available in Large sizes. The gowns are non-sterile, single-use devices.
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K Number
K202607Device Name
Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs
Manufacturer
Date Cleared
2021-04-23
(226 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
String King Lacrosse, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The disposable surgical face 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 3-ply surgical mask is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
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