(80 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML capabilities.
No
The device is a medical glove intended to prevent contamination between patient and examiner, not to provide therapy or treatment to a patient.
No
The device, a disposable examination glove, is intended for medical purposes to prevent contamination between patient and examiner, not to diagnose any condition.
No
The device description clearly states it is a physical glove, a disposable device worn on the hand, and describes its material (nitrile), physical properties (powder-free, ambidextrous, sizes), and testing against physical standards (ASTM). There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a disposable device worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier device for personal protection and infection control.
- Device Description: The description focuses on the physical properties and testing related to barrier function and resistance to chemicals.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This glove's function is purely protective.
N/A
Intended Use / Indications for Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, ODO
Device Description
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension.
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Irritation.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
Key results:
- Physical Dimensions (Length, Palm Width, Thickness): Pass
- Physical Properties (Tensile Strength, Elongation): Pass
- Water leak test (AQL 2.5): Pass
- Powder Residue (Max 2mg/glove): Pass
- Permeation by Chemotherapy Drugs: Pass (Refer to table for specific breakthrough detection times)
- Irritation and Skin Sensitization: Is non-sensitization and Non-irritation
- Cytotoxicity: showed potential toxicity to L929 cells.
- Acute systemic toxicity study: no evidence of systemic toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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 rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2023
Shanxi Hongjin Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K230779
Trade/Device Name: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: March 20, 2023 Received: March 21, 2023
Dear Kathy Liu:
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 (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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230779
Device Name
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentany) Citrate
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X 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."
3
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
The assigned 510(K) numbers: K230779 Date Prepared: June 08, 2023
1. Owner's Identification:
Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province Email: fdareg(@hongray.com.cn
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Comfort Rubber Gloves Industries Sdn. Bhd. Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)
4. Device Description:
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
The Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019) The following chemicals have been tested with these gloves:
K230779 । । ર
4
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in
Minutes |
|------------------------------------------|---------------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 11.3 minutes, Thiotepa: 24.7minutes, Or
*Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of Subject Device and Predicate Device:
| | Subject Device
K230779 | Predicate Device
K192954 | Comparison |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Powder Free Nitrile
Examination Gloves (Black),
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate | Blue Colored, Power Free Nitrile
Examination Gloves Tested for
Use with Chemotherapy Drugs and
Fentanyl Citrate | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Powder Free Nitrile Examination
Gloves (Black), Tested for Use
with Chemotherapy Drugs and
Fentanyl Citrate is a disposable
device intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between patient
and examiner. Gloves have been
tested for use with chemotherapy
drugs and Fentanyl Citrate using
ASTM D6978 | Blue Colored, Powder Free Nitrile
Examination Gloves, Non-sterile,
and Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate is a patient medical exam
glove which is a disposable device
intended for medical purpose that is
worn on the examiner's hand or
finger to prevent contamination
between examiner and patient.
Glove was tested for use with
Chemotherapy Drugs and Fentanyl
Citrate as per ASTM D6978 | Similar |
5
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County,
Linfen City, Linfen City, Shanxi Province
| Material | Nitrile | Nitrile | Same |
|---|---|---|---|
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Color | Black | Blue | Different |
| Single use | Single use | Single use | Same |
| Chemotherapy Drugs | |||
| and Fentanyl Citrate | |||
| Claim | See below comparison table | See below comparison table | See below |
| comparison | |||
| table |
Technological Characteristic Comparison Table:
| Technological
Characteristics | Subject Device
K230779 | Predicate Device
K192954 | Comparison |
|---------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------|------------|
| Length | Minimum 230mm | Minimum 240mm | Similar |
| Palm Width (size) (mm) | | | |
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | N/A | Different |
| Thickness(mm) | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,
Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, After
Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, After
Accelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20
ASTM D5151
AQL 2.5 | 21 CFR 800.20
ASTM D5151
AQL 2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | Same |
| 10993-23:2021 Skin Irritation
Study | Under the conditions of
the study, not an irritant | Under the conditions of the
study, the subject device is
non-irritating | Same |
| 10993-10:2021 Maximization
Sensitization Study | Under the conditions of the
study, not a sensitizer | Under the conditions of the
study, the subject device is
non sensitization | Same |
6
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| 10993-5:2009 Cytotoxicity
Test | Under the conditions of this
study, the test article extract
showed potential toxicity to
L929 cells. | Exhibits severe cytotoxicity
reactivity at 100%, and 66%
extract concentrations and no
cytotoxicity reactivity at 44%,
30%, 20% and 15% extract
concentrations under the
condition of this test. | Similar |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO 10993-11:2017 Acute
Systemic toxicity study | Under the conditions of this
study, there was no evidence of
systemic toxicity. | Under the conditions of the
study, the subject showed no
adverse biological reaction. | Same |
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and
| Concentration | Minimum BDT (Minutes) | Comparison | |
|---|---|---|---|
| Subject Device | |||
| K230779 | Predicate Device | ||
| K192954 | |||
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 | 18.2 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | N/A | Different |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 | 57.3 | Similar |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
7. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions | ||
| Length | Minimum 230mm for all | ||
| sizes | Pass | ||
| ASTM D6319- 19 | Physical Dimensions | ||
| Palm Width | XS: 70±10mm | ||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | |||
| XL: 120±10mm XXL: | |||
| 130±10mm | Pass | ||
| ASTM D6319- 19 | Physical Dimensions | ||
| Thickness | Finger: 0.05mm (min) | ||
| Palm: 0.05mm (min) | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 | |
| MPa) and Elongation | |||
| (Before Aging 500% and | |||
| after aging 400%) Min | Pass |
7
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| ASTM D6319-19
| ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
|---|---|---|---|
| ASTM D6319-19 | |||
| ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by | ||
| Chemotherapy Drugs | Refer the above table | Pass | |
| ISO 10993-10 &23:2021 | Irritation and Skin | ||
| Sensitization | Skin sensitization and Skin | ||
| irritation | Is non-sensitization | ||
| and Non-irritation | |||
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential |
| toxicity to L929 cells. | |||
| ISO 10993-11:2017 | Acute systemic toxicity | ||
| study | Subject showed no adverse | ||
| biological reaction | no evidence of | ||
| systemic toxicity. |
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ●
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ●
- . ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by . Chemotherapy Drugs.
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization. .
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ●
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Irritation. ●
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●
8. Clinical Performance Data
N/A
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.