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KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: · Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200. · 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200. KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used. Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles. These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectanqular fabric produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The wrap fabric (white or blue color) is composed of polypropylene with the addition of less than 2% by weight of phthalocvanine blue pigment (blue fabric only), less than 1% by weight titanium dioxide pigment, and less than 0.009% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using: - V-PRO® 60 Low Temperature Sterilization System that include: - o Lumen Cycle - Non Lumen Cycle o - Flexible Cycle O KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously. The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using: Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 STERRAD® NX® [Standard Cvcle. Advanced Cvcle] STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle] KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used. Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, EXPRESS Cycle, DUO Cycle]). The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1. KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbond-meltblown-spunbond) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using: - Gravity Steam at 250°F/121°C for 30 minutes. . KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of antistatic treatment. The wrap allows a sterilized package to be opened aseptically.

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using: - Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 o - STERRAD® NX® [Standard Cycle, Advanced Cycle] o - STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o Cycle] KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.