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510(k) Data Aggregation

    K Number
    K240910
    Device Name
    EO Chex Indicator Tape
    Manufacturer
    Propper Manufacturing Co., Inc.
    Date Cleared
    2024-06-12

    (71 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Propper Manufacturing Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterlization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items. The EO Chex indicator tape can be used in the following EO sterilization cycles: 1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure 2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure 3. 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer 4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure 5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure
    Device Description
    The EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization. The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown. The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser. The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity, and concentration of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming an orange-brown compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve the required level, the indicator ink chemistry changes color from pink to orange-brown. If the parameters do not achieve the required level, the indicator color remains as any shade of pink.
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    K Number
    K222137
    Device Name
    OK Plus Indicator
    Manufacturer
    Propper Manufacturing Co., Inc.
    Date Cleared
    2022-12-05

    (139 days)

    Product Code
    JOJ, DAT
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Propper Manufacturing Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterlization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: *Gravity: 121 C/250 F - 30 minutes * Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes * Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes * Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes * Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes - *Vacuum assisted (prevacuum): 135 C/275 F 3 minutes The OK Plus indicator has the following Stated Values determined in Resistometer: * 121 C/250 F - 15 minutes * 132 C/270 F - 4 minutes * 134 C/273 F - 3 minutes * 135 C/275 F - 2.9 minutes
    Device Description
    The OK Plus indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. OK Plus indicators are sold in boxes of 250 strips. The indicator responds to all critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from off-white to black. If the parameters do not achieve the required level, the indicator color will be light brown or brown.
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    K Number
    K212592
    Device Name
    Gas-Chex Indicator
    Manufacturer
    Propper Manufacturing Co., Inc.
    Date Cleared
    2022-01-20

    (157 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Propper Manufacturing Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gas-Chex Indicator is an integrating indicator designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 1. 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure 4. 38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure 5. 55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure 6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure 7. 55°C. 600 mg/l EO. 60% RH. 4 hours exposure The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer: 54℃, 42 min, EO 600 mg/l, RH 60±10% 37℃,75 min. EO 600 mg/l. RH 60±10% 55°C, 36 min, EO 736 mg/l, RH 50±10% 37°C, 75 min, EO 736 mg/l, RH 50±10% 55°C, 35 min, EO 759 mg/l, RH 50±10% 37°C, 75 min, EO 759 mg/l, RH 50±10%
    Device Description
    The Gas-Chex® Indicator is a single use chemical integrating indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. Gas-Chex® Indicators are sold in boxes of 250 strips. The indicator responds to all critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During sterilization process the indicator ink chemicals react to EO gas forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from brown-red to green. If the parameters do not achieve the required level, the indicator color will be brown-red, or brown-yellow.
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    K Number
    K210866
    Device Name
    Steri-Dot Process Indicator
    Manufacturer
    Propper Manufacturing Co., Inc.
    Date Cleared
    2021-06-21

    (90 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Propper Manufacturing Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items. The Steri-Dot process indicator can be used in the following EO sterilization cycles: 1. 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure 4. 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure 5. 55°C, 759 mg/l EO, ≥35% RH, l hour exposure 6. 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure
    Device Description
    The Steri-Dot Process Indicator is a single use chemical indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a substrate paper circle, 3/4" or 1" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only. The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from purple-red to green. If the parameters do not achieve the required level, the indicator color will be brown or red.
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    K Number
    K210553
    Device Name
    Steam-Dot Process Indicator
    Manufacturer
    Propper Manufacturing Co., Inc.
    Date Cleared
    2021-05-19

    (83 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Propper Manufacturing Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steam-Dot Process Indicator for steam sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed units or loads. The indicator dots turn from white to dark brown/black when sterilization conditions, thus providing an indication of processed items. The Steam-Dot process indicator can be used in the following steam sterilization cycles: *Gravity: 121 C/250 F - 30 minutes - * Vacuum assisted (pre-vacuum): 132 C/270 F 3 minutes - * Vacuum assisted (pre-vacuum): 132 C/270 F 4 minutes - * Vacuum assisted (pre-vacuum): 134 C/273 F 3 minutes - * Vacuum assisted (pre-vacuum): 134 C/273 F 4 minutes - * Vacuum assisted (pre-vacuum): 135 C/275 F 3 minutes
    Device Description
    The Steam-Dot Process Indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a substrate paper circle, 3/4" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only. The indicator responds to the critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from white to black/dark brown. If the parameters do not achieve the required level, the indicator color will be light brown or crème.
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