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510(k) Data Aggregation
K Number
K171533Device Name
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
Manufacturer
Ahlstrom Nonwovens LLC
Date Cleared
2017-06-29
(35 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Ahlstrom Nonwovens LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
- Pre-vacuum Steam 270°F/132°C for 4 minutes
- Gravity Steam 250°F/121°C for 30 minutes
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes
- Advanced Sterilization Products (ASP) STERRAD® 100S
- Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
- STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Device Description
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings:
Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.
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K Number
K160755Device Name
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
Manufacturer
AHLSTROM NONWOVENS LLC
Date Cleared
2016-07-27
(131 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
AHLSTROM NONWOVENS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
- Pre-vacuum Steam 270°F/132°C for 4 minutes
- Gravity Steam 250°F/121°C for 30 minutes
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% 80% relative humidity for 60 minutes
- Advanced Sterilization Products (ASP) STERRAD® 100S
- Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
- STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Device Description
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings:
Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.
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