Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder

Q: Who is the manufacturer of Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

Jiangsu Kangbao Medical Equipment Co., Ltd. filed the 510(k) submission for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder (K232881).

Q: What is the FDA product code for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

JKA. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

Bevel Up Holder (K193074); Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (K214075).

Q: Who can help prepare an FDA 510(k) submission like Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K232881 · Jiangsu Kangbao Medical Equipment Co., Ltd. · JKA · Dec 22, 2023 · Clinical Chemistry

Device Facts

Record ID	K232881
Device Name	Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
Applicant	Jiangsu Kangbao Medical Equipment Co., Ltd.
Product Code	JKA · Clinical Chemistry
Decision Date	Dec 22, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Intended Use

Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury. Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.

Device Story

Single-use, sterile winged needles bonded to flexible tubing with Luer connectors; optional needle holder for blood collection tubes. Safety versions feature a manual sliding shield mechanism that locks over the needle post-venipuncture to prevent needlestick injuries. Used by trained healthcare professionals in clinical settings for routine venipuncture or short-term fluid infusion. Healthcare providers manually activate the safety shield by sliding it forward and pulling the tubing until an audible click confirms locking. The device facilitates blood specimen collection or fluid administration; the safety feature reduces occupational exposure to bloodborne pathogens.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ISO 8536-4, ISO 9626, ISO 7864, ISO 80369-7/20, and ISO 23908. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, reactivity, systemic toxicity, coagulation, hemolysis, Ames test, chromosomal aberration). Sterilization validated per ISO 11135.

Technological Characteristics

Materials: SUS304 (needle), PVC (tubing), ABS (Luer adapter), HDPE (sheath), Polypropylene (safety shield/holder), Isoprene Rubber (sleeve). Lubricated with silicone oil; bonded with epoxy resin. EO sterilized. Connectivity: Luer port for standard accessories. Standards: ISO 9626, ISO 7864, ISO 80369-7/20, ISO 23908, ISO 8536-4, ISO 10993, ISO 11135.

Indications for Use

Indicated for venous blood collection or short-term (≤2 hours) intravenous fluid infusion. For use by trained healthcare professionals. Safety versions include a shield to protect against accidental needlestick injury.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

Bevel Up Holder (K193074)
Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (K214075)

Related Devices

K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Apr 12, 2022
K013164 — SURSHIELD SAFETY WINGED BLOOD COLLECTION SET · Terumo Medical Corp. · Oct 15, 2001
K211293 — Safety Winged Blood Collection Sets · Promisemed Hangzhou Meditech Co., Ltd. · Jun 25, 2021
K031279 — SURSHIELD SAFETY WINGED BLOOD COLLECTION SET · Terumo Medical Products Hangzhou Co., Ltd. · May 30, 2003
K011786 — VACUETTE SAFETY BLOOD COLLECTION SET · Greiner Vacuette North America, Inc. · Jul 12, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 22, 2023 Jiangsu Kangbao Medical Equipment Co., Ltd Wenbin Fan Deputy General Manager 78#, North Suzhong Road, Baoying Yangzhou, Jiangsu 225800 China Re: K232881 Trade/Device Name: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FMI, FPA Dated: November 21, 2023 Received: November 22, 2023 Dear Wenbin Fan: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director {2}------------------------------------------------ DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232881 #### Device Name Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder #### Indications for Use (Describe) Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury. Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |---------------------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) SUMMARY K232881 | Preparation Date: | December 22, 2023 | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer's Name and Address: | Jiangsu Kangbao Medical Equipment Co., Ltd 78#, North Suzhong Road Baoying, Yangzhou, Jiangsu, China 225800 Tel. +86-514-88223540 Fax +86-514-88232089 | | Corresponding Official: | Charles Mack | | Telephone Number: | 931-625-4938 | | Email Address: | charliemack@irc-us.com | | Trade Name: | Winged Infusion Set. Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder. Safety Blood Collection Set, Safety Blood Collection set with Holder, Needle Holder | | Common Name(s): | Tubes, Vials, Systems, Serum Separators, Blood Collection | | Regulation Name(s): | Blood specimen collection device | | Regulation Number(s): | 21 CFR 862.1675 | | Primary Product Code: Subsequent Product Codes: | JKA FMI, FPA | | Device Class: | Class II | {5}------------------------------------------------ | Primary Predicate Device: | K193074 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | Bevel Up Holder | | Common Name: | tubes, vials, systems, serum separators, blood collection | | Regulation Number: | 21 CFR 862.1675 | | Product Code: | JKA | | Predicate Device: | K214075 | | Trade Name: | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | | Common Name: | needle, hypodermic, single lumen | | Regulation Number: | 21 CFR 880.5570 | | Product Code: | FMI, FPA | ## Device Description: The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc. The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc. The safety feature is operated by releasing a latch mechanism whereby the user slides a winged cover over the needle as it is removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable. The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids. #### Indications for Use Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. {6}------------------------------------------------ Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection aqainst accidental needle stick injury. Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles, and tubes. It is to be used by trained healthcare professional only. {7}------------------------------------------------ ## Needle Holder | Feature | Subject Device | Predicate Device | Discussion | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | 510(K) | K232881 | K193074 | - | | Device Name | Needle Holder | BEVEL UP HOLDER | - | | Indication for Use | The Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles, and tubes. It is to be used by trained healthcare professional only. | The Bevel Up Holder is used for the collection of blood into blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles, and tubes. The device is to be used by trained healthcare professional only. | Identical | | Product Configuration | Clear plastic holder | Clear plastic holder | Identical | | Material | Polypropylene | Polypropylene | Identical | | Sterility | They are not sterilized when provided alone. Sterilized when provided attached to the blood collection set | Not sterilized | Note 1 | | Packaging | Bulk pack in poly bag or Blister packaging | Bulk pack in poly bag | Note 2 | | Use | Single use | Single use | Identical | | Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1 | Identical | | Shelf Life | Complies with ASTM F1980 5 years | 3 years | Note 3 | | Feature | Subject Device | Predicate Device | Discussion | | 510(K) | K232881 | K214075 | | | Device Name | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | Safety Blood Collection / Infusion Set (with/without needle holder). Blood Collection / Infusion Set (with/without needle holder) | | | Indication for Use | Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Winged Infusion Set is indicated for the short- term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. | The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. | Similar Note 1 | | Feature | Subject Device | Predicate Device | Discussion | | 510(K) | K232881 | K214075 | - | | | Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only. | | | | Safety Feature | The needle is locked in safety sheath after use for the Safety Blood Collection / Winged Infusion Set (with/without needle holder). Slide the safety shield forward and pull the tubing backward until an audible click is heard. There is no safety mechanism for the Blood Collection Set / Winged Infusion Set (with/without needle holder). | For the Safety Blood Collection / Infusion Set (with/without needle holder), the needle is locked in safety sheath after use by sliding the safety shield forward with pulling the tubing backward until an audible click is heard. For the Blood Collection / Infusion Set (with/without needle holder), no safety mechanism. | Identical | | Material | | | | | Needle tube | SUS304 | SUS304 | Identical | | Flexing tube | PVC | PVC | Identical | | Luer adapter | ABS | ABS | Identical | | Needle sheath | HDPE | HDPE | Identical | | Safety shield | Polypropylene | Polypropylene | Identical | | Rub sleeve | Gather Isoprene Rubber | Gather Isoprene Rubber | Identical | | Feature | Subject Device | Predicate Device | Discussion | | 510(K) | K232881 | K214075 | - | | Lubricate | Silicone oil | Silicone oil | | | Adhesive | Epoxy Resin | Epoxy Resin | | | Needle Gauge | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G; | Identical | | Needle Length | 1/2" - 1 1/8" | 1/2" - 1 1/8" | Identical | | Flexing tubing Length | 4"; 7½"; 12" | 7½"; 12" | Note 2 | | Hub/Needle bond strength | Complies with ISO7864 | Complies with ISO7864 | Identical | | Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | Identical | | Performance | Complies with ISO 9626 ISO 7864 ISO 80369-7 ISO 80369-20 ISO 23908 ISO 6009 ISO 8536-4 | Complies with ISO 9626 ISO 7864 ISO 80369-7 ISO 80369-20 ISO 23908 ISO 6009 ISO 8536-4…