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510(k) Data Aggregation
K Number
K230707Device Name
Skypro, Surgical Gown 6021
Manufacturer
Skypro Medical Supplies Company
Date Cleared
2023-10-12
(212 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Skypro Medical Supplies Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
Device Description
"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
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K Number
K202255Device Name
Skypro, SP02 Mask (3)
Manufacturer
Skypro Medical Supplies Company
Date Cleared
2021-12-24
(501 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Skypro Medical Supplies Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Skypro, SP02 Mask (Level 3)" is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended for infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.
Device Description
"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.
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K Number
K152197Device Name
Skypro, SP01 Mask
Manufacturer
Skypro Medical Supplies Company
Date Cleared
2016-08-26
(387 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Skypro Medical Supplies Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skypro, SP01 Mask is 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 of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
Device Description
Skypro, SP01 Mask, is a flat pleated procedure or surgical mask. It is 3 layers and composed of Polypropylene and Meltblown, with elastic earloops or Ties in either knitted polyester/lycra or non-woven polyester and A malleable nosepiece is placed within the bindings for comfort and individualized fir around the wearer's nose.
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