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A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

The Crosstex VH2O2 Chemical Indicators are intended for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX, and Sterilucent™ PSD-85 sterilization processes. The Crosstex VH2O2Chemical Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Chemical indicators change to a color of blue after exposure to vaporized hydrogen peroxide. Colors other than blue such as yellow/green should be treated as a process failure.

The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.

The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time. The test pack consists of multiple layers of paper cards with a SporView Rapid Read Biological Indicator, chemical process indicators and load record card. The load record card is used to record the detailed information from the sterilization cycle. The SporView Rapid Read Biological Indicator, cleared under 510(k) K172432, is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.

The SporView® Rapid Read Biological Indicator is intended to be used with the 3M Attest Auto-Reader to monitor the effectiveness of dynamic-air-removal (prevacum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.

The SporView Rapid Read Biological Indicator is a self-contained biological indicator designed to be used with the 3M Attest 390 auto-reader to qualify or routinely challenge dynamic-airremoval (pre-vacuum) steam sterilization cycles of 4 minutes at 270°F (132°C). The SporView Rapid Read Biological Indicator is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap. Similar to the predicate device, 3M's 1292 Rapid Read-Out Biological Indicator cleared under 510(k)s K090569 and K926364, the subject device contains ≥ 105 viable spore population of G. stearothermophilus. It utilizes the a-glucosidase system, which is generated naturally within growing G. stearothermophilus. A successful steam sterilization cycle will result in no growth of G. stearothermophilus. A failure in the sterilization cycle creates a fluorescence change, which is detected upon incubation in the 3M 390 Attest Auto-reader. This provides an enzymatic result in 3 hours to indicate a steam sterilization process failure. The biological indicator will also detect the presence of G. stearothermophilus organism by a visual color change reaction. Biochemical activity of the orqanism will produce acid by-products that cause the media to change color after 48 hours. A visual pH color change after 48 hours also indicates a steam sterilization process failure.

A chemical indicator for monitoring all cycles within the STERIS® V-PRO™ 60 (Flexible, Lumen & The VH2O2 Indicators are intended to be used by health care providers with Non-lumen). sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

The SPSmedical VH2O2 External Indicators are single use process indicators, intended for use in verifying exposure to all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and Sterilucent™ PSD-85 sterilizers. For purposes of this submission testing has been performed to validate the SPSmedical VH2O2 External Indicators for use in the Steris® V-PRO® 60 sterilizer. Indicators will identify if an item has seen vaporized hydrogen peroxide during the Steris® V-PRO® 60 sterilization processes by changing from a pink to a blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items. Physical Properties: The SPSmedical VH2O2 External Indicators consist of two (2) devices, an indicator label and an indicator card. These devices have minor physical differences. The label has an adhesive backing while the card does not. They use the same manufacturing process and are printed on the same substrate. Technical Characteristics: The chemical indicator ink utilized on the SPSmedical VH2O2 External Indicators has been formulated to meet the performance requirements ANSVAAMI/ISO 11140-1 for Process Indicators. Functional Characteristics: The SPSmedical VH2O2 External Indicators are designed to monitor sterilization cycles in low temperature vaporized hydrogen peroxide sterilizers. They are a reliable tool used for the monitoring of vaporized hydrogen peroxide sterilization processes and provide a visual indication that hydrogen peroxide (H2O2), an essential ingredient in the vaporized hydrogen peroxide sterilization process has been introduced into the sterilizer's chamber. Indicators will identify if an item has seen H2O2 during the sterilization process. Indicators change from an initial color of pink to a final signal color of blue.

A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO™ 1, V-PRO" 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

The SPSmedical VH2O2 Indicators are single use process indicators which are cleared for use in verifying exposure to all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-Pro 1, V-Pro 1 Plus, and V-Pro maX Testing has been performed which validated the SPSmedical VH2O2 Indicators for use in the Sterilucent PSD-85 Sterilizer. Indicators will identify if an item has seen H2O2 during the Sterilucent PSD-85 sterilization processes by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.

The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine monitoring and sterilizer qualification testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time.

The SporView® Plus BI Test Pack is a single use device designed to assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes. It consists of layers of paper with a biological indicator and a load record card with chemical integrator placed in the center and all placed within an exterior containment box. A process indicator label placed on the containment box alerts users if a pack has been exposed to the sterilization process. The approximate dimensions of the pack are 4-5/8" x 7/8" x 6-1/4". The load record card is used to record all the detailed information from the sterilization cycle. The subject device replaces the biological indicator in the predicate device with the SporView® 10 Steam Self Contained Biological Indicator.

The AirView™ II Bowie Dick Test Pack is intended for the daily air removal efficacy testing of prevacuum steam sterilizers. It may also be used after sterilizer installation, relocation, after major repairs and after sterilization process failures. The AirView" II Bowie Dick Test Pack is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 134°C for 3.5 minutes. The indicator sheet within the AirView II Bowie Dick Test Pack will demonstrate a uniform color change from blue to dark brown black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1° /-0°C) temperature difference between the center of the towel pack. as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the AirView" II Bowie Dick Test Pack will demonstrate a non-uniform color change.

Functionality-The AirView™ II Bowie Dick Test Pack is designed for routine testing of 134°C ' (273°F) prevacuum steam sterilizers. The Bowie Dick test is part of the daily release criteria for any prevacuum steam sterilizer. It may also be used after sterilizer installation, relocation, malfunction, after major repairs and after sterilization process failures. The AirView™M II Bowie Dick Test Pack should always be run in an empty chamber. Scientific Concepts-The Bowie Dick Test should be run only after the chamber has been preheated. It is a means of detecting air leaks in gaskets or chamber piping, poor air removal and subsequent steam penetration. The AirView™ II Bowie Dick Test Pack has proven safe and effective as a replacement for the standard Bowie Dick Towel Pack through validated performance testing. Physical Characteristics-The AirView™ II Bowie Dick Test Pack consists of layers of paper with an air removal indicator placed in the center of the stack all placed within an exterior containment box. A process indicator label placed on the containment box alerts users if a pack has been exposed to the sterilization process. The approximate dimensions of the pack are 3-3/4" x 5/8" x 5". The air removal indicator within the AirView™ II Bowie Dick Test Pack should be retained as a permanent record while the remainder of the pack can be discarded with regular waste according to local legislation, recycling land filling or incineration. None of the AirView™ II Bowie Dick Test Packs components are made from lead. Performance Characteristics-The AirView™ II Bowie Dick Test Pack performs substantially equivalent to the AAMI Standard Towel Pack when tested in conformance with the FDA guidance document for Chemical Indicators and ANSI/AAM1/ISO 11140-5.

The following Crosstex® Isofluid Plus Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. (non-sterile) - Crosstex® Isofluid Plus Surgical Earloop Face Mask Blue . - Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask Blue . - Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask with Splash Visor Blue .

The Crosstex Isofluid Plus Surgical Masks are constructed of a cellulose inner facing, a 100% Spundonded porypropyitent elastic loops. The nose piece for the polypropyiene inter firedia, with non facil cae no fog strip (if applicable) is made of melt blow polypropylene.

The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. - Crosstex® Surgical Earloop Mask White ● - Crosstex® Surgical Earloop No Fog Mask White . - Crosstex® Surgical Earloop No Fog Mask with Splash Visor White .

The Crosstex Surgical Masks are constructed of a cellulose inner facing, a 100% spunbonded polypropylene white outer facing, a 100% meltblown polypropylene filter media, with white non-latex elastic loops. The nose piece for the Crosstex Surgical Masks is aluminum wire while the no fog strip (if applicable) is made of melt blow polypropylene.

The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. - Crosstex® Isolite® Earloop Face Masks Blue, Pink . - Crosstex® Isofluid® Earloop Face Masks Blue, Pink, White, Green . - Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach . - Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ● - . Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow - Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue . - Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor Blue ●

The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of tissue or 100% spunbonded polypropylene, a 100% meltblown polypropylene filter media, with white elastic loops and/or a fogfree strip. The nose piece for all seven (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).