Search Results
Found 12 results
510(k) Data Aggregation
K Number
K241214Device Name
ProPel SG3 Surgical Gown
Manufacturer
Standard Textile Co., Inc.
Date Cleared
2024-09-10
(133 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Standard Textile Co., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProPel SG3TM Surgical Gown is 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.
The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Stertlization parameters are as follows:
Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)
Device Description
The ProPel SG3TM Surgical Gown is a reusable, woven surgical gown that provides an ANSI /AAMI PB70:2022 Level 3 Liquid Barrier Performance Barrier using 100% polyester with silicone coating in the critical zone. The critical zone inner ply and back of the surgical gown is made of polyester with electrostatic dissipative yarn (graphene) and silicone coating. The gown has polyester mesh and vented cape on the back panels of the gown for ventilation. The ProPel SG3TM Surgical Gown may undergo up to 60 reprocessing cycles.
The ProPel SG3™ Surgical Gown is available in small, medium, large, extra large (XL), 2XL and 3XL. The device will be sold as a non-sterile surgical gown that is to be laundered, sterilized and processed by the healthcare facility prior to first use and after each subsequent use.
Ask a Question
K Number
K172207Device Name
Standard Supreme Sterilization Wrapper
Manufacturer
Standard Textile Co., Inc.
Date Cleared
2017-08-25
(35 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Standard Textile Co., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Standard Supreme Sterilization Wrappers are intended to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain steriity of the enclosed device until used.
Standard Supreme Sterilization Wrappers will function as a sterlization wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterily sterilization wraps that are intended to be sterlized and processed by heath care facilities and/or contract sterilization/laundry companies.
Device Description
Standard Supreme Sterilization Wrappers are made from Standard Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric and then dyed. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31.
Ask a Question
K Number
K162162Device Name
Barrier Supreme Sterilization Wrapper
Manufacturer
Standard Textile Co., Inc.
Date Cleared
2016-11-04
(94 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Standard Textile Co., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Barrier Supreme Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Barrier Supreme Sterilization Wrappers will function as a sterilization wrap when processed according to instructions. Barrier Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterilization wraps that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Device Description
Barrier Supreme Sterilization Wrappers are made from Barrier Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric, dyed and treated with a fluoropolymer finish. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31.
Ask a Question
K Number
K060181Device Name
COMPE1 1 -PLY SURGICAL GOWNS
Manufacturer
STANDARD TEXTILE CO., INC.
Date Cleared
2006-03-07
(43 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
STANDARD TEXTILE CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.
When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable through 125 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.
Device Description
All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 125 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.
Ask a Question
K Number
K041653Device Name
COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
Manufacturer
STANDARD TEXTILE CO., INC.
Date Cleared
2005-07-01
(379 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
STANDARD TEXTILE CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids across critical areas of the gown.
When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable medical devices that are intended to be processed through 100 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.
Device Description
All the components used in these ComPel® Gowns are made from 100% Dacron. All the ouripented acomPel fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 100 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.
Ask a Question
K Number
K041540Device Name
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
Manufacturer
STANDARD TEXTILE CO., INC.
Date Cleared
2005-05-05
(331 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
STANDARD TEXTILE CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
COMBOsafe/Promax Surgical Gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown. COMBOsafe/Promax Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Device Description
All fabric components used in COMBOsafe™ Surgical Gowns are made from 100% polyester. dyed blue and/or green and are laminated with a urethane film. COMBOsafe Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Ask a Question
K Number
K041539Device Name
COMPEL SURGICAL GOWNS
Manufacturer
STANDARD TEXTILE CO., INC.
Date Cleared
2005-04-28
(324 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
STANDARD TEXTILE CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ComPel Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.
Surgical gowns may provide different levels of protection dependent upon the fabric materials used and the placement of such materials in the final design of the gown.
When processed according to instructions, ComPel Surgical gowns will function and perform as a surgical gown. The ComPel Surgical gowns are reusable through 75 wash, dry, and sterilization cycles. The gowns are manufactured and distributed as non-sterile surgical gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.
Device Description
ComPel® 'O' Surgical Attire/Gowns. All the components used in ComPel® Surgical Gowns are made from 100% Dacron polyester filaments. ComPel 'O' fabrics are dyed and treated with a fluorocarbon finish. ComPel® 'O' Surgical Gowns will function as surgical attire when processed according to instructions through 75 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed (wash/dried) by health care facilities and/or contract sterilization/laundries companies. ComPel® 'O' Surgical Gowns are intended to be used as surgical attire in an operating theater. The liquid barrier properties will inhibit the migration of liquids across its surface. Per ANSI/AAMI PB70:2003 standard, the 2-ply gowns with the flat felled seam design are classified as a Level 2 Barrier.
Ask a Question
K Number
K041541Device Name
COMPEL MLR SURGICAL GOWNS
Manufacturer
STANDARD TEXTILE CO., INC.
Date Cleared
2005-03-16
(281 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
STANDARD TEXTILE CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ComPel MLR Surgical gowns are medical devices that are intended to be worn by operating room personnel to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.
Surgical gowns may provide different levels of protection dependent upon the fabric materials used and the placement of such materials in the final design of the gown.
When processed according to instructions, ComPel MLR Surgical gowns will function and perform as a barrier through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns and are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Device Description
All fabric components used in ComPel® 3000 Surgical Gowns are made from 100% polyester, solution luble outer for the outer ComPel 3000 layer and non-dyed filaments with carbon yarns for the inner layer, and are treated with a fluorochemical finish.
ComPel® 3000 Surgical Gowns will function as a surgical attire when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
ComPel® 3000 Surgical Gowns are intended to be worn by personnel functioning in the surgical theater and will be put in all critical areas of the product where liquid protection is needed. The liquid barrier properties with minon the migrated "inverted" 2-ply sleeve designs are classified as a Level 3 Barrier.
Ask a Question
K Number
K012268Device Name
TRIMAX
Manufacturer
STANDARD TEXTILE CO., INC.
Date Cleared
2001-12-03
(137 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
STANDARD TEXTILE CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Device Description
All fabric components used in TriMax Surgical Gowns are made from 100% polyester. TriMax Surgical Gown will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Ask a Question
K Number
K012807Device Name
MODIFICATION TO: COMPEL SURGICAL DRAPES
Manufacturer
STANDARD TEXTILE CO., INC.
Date Cleared
2001-10-11
(50 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
STANDARD TEXTILE CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ComPel Surgical Drapes are intended to cover patients or working surfaces during surgical procedures. ComPel Surgical Drapes and Covers are made of synthetic materials intended to be used as protective other of Dargious such as to isolate a site of surgical incision from microbial and other contamination.
ComPel Surgical Drapes will function as a surgical drape when processed according to instructions. Com of Dargical Drapes are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Device Description
All base fabrics used in the construction of ComPel Surgical Drapes are made from 100% polyester, knitted or woven into fabric and then dyed. WrapPel and ComPel fabrics are fluorocarbon treated, XTR fabric is silicone coated, COMBOsafe fabric is laminated with a urethane film and Zorwik is treated to be hydrophilic. ComPel Surgical Drapes will function as a surgical drape when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Ask a Question
Page 1 of 2