(184 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 technology.
No
This device, a blue nitrile examination glove, is intended to prevent contamination and protect the examiner, not to provide therapy to a patient.
No
The device is described as a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This indicates its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical glove made from acrylonitrile-butadiene copolymer dispersion, which is a hardware component.
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 intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and materials of the glove, and its compliance with standards for medical gloves and resistance to certain substances. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose. The testing performed is related to the glove's barrier properties and safety for the user and patient.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is a protective barrier.
N/A
Intended Use / Indications for Use
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|---|---|
| Bendamustine (5 mg/ml) | >240 Minutes |
| Bleomycin (15 mg/ml) | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes |
| Carfilzomib (2 mg/ml) | >240 Minutes |
| Cetuximab (2 mg/ml) | >240 Minutes |
| Cladribine (1 mg/ml) | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes |
| Decitabine (5 mg/ml) | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes |
| Fulvestrant (50 mg/ml) | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes |
| Mechlorethamine (1 mg/ml) | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes |
| Oxaliplatin (5 mg/ml) | >240 Minutes |
| Paraplatin (10 mg/ml) | >240 Minutes |
| Pemetrexed (25 mg/ml) | >240 Minutes |
| Raltitrexed (0.5 mg/ml) | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes |
| Topotecan (1 mg/ml) | >240 Minutes |
| Triclosan (2 mg/ml) | >240 Minutes |
| Trisenox (1 mg/ml) | >240 Minutes |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes |
| Vinblastine (1 mg/ml) | >240 Minutes |
| Vinorelbine (10 mg/ml) | >240 Minutes |
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml)
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes
Warning: Do not use with Carmustine or Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is available in Small, Medium, Large and Extra Large sizes.
The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purpose
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 Testing Summary Performance Data. Test methods and results are provided for:
- ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine length, width, thickness, tensile strength, and ultimate elongation of the gloves).
- Length results: Small:- 404 mm, Medium:- 405 mm, Large:- 405 mm, X-Large:- 406 mm. All passed acceptance criteria of Min 220 mm for Size Small & Min 230 mm for all other sizes.
- Width results: Small:- 84 mm, Medium:- 94 mm, Large:- 105 mm, X-Large:- 115 mm. All passed within the specified +/- 10 mm tolerance for each size.
- Thickness results: Small 0.19mm Palm, 0.21mm Finger; Medium 0.19mm Palm, 0.21mm Finger; Large 0.19mm Palm, 0.21mm Finger; X-Large 0.19mm Palm, 0.21mm Finger. All passed acceptance criteria of Palm 0.05 mm min, Finger 0.05 mm min.
- Physical properties (Tensile strength): Before Ageing: Small 22.77Mpa, Medium 24.46Mpa, Large 24.51Mpa, X-Large 24.59Mpa. All passed acceptance criteria of 14Mpa Min. After Ageing: Small 20.50Mpa, Medium 21.81Mpa, Large 21.95Mpa, X-Large 22.05Mpa. All passed acceptance criteria of 14Mpa Min.
- Physical properties (Ultimate Elongation): Before Ageing: Small 885%, Medium 888%, Large 891%, X-Large 892%. All passed acceptance criteria of 500% Min. After Ageing: Small 868%, Medium 870%, Large 872%, X-Large 875%. All passed acceptance criteria of 400% Min.
- ASTM D5151-2019 Standard Test Method for Detection of Holes in Medical Gloves (To determine the holes in the gloves). Result: Gloves Passes AQL 1.5. Acceptance Criteria: Passes AQL-2.5.
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves (To determine the residual powder in the gloves). Result: Small 0.16 mg/glove, Medium 0.16 mg/glove, Large 0.16 mg/glove, X-Large 0.16mg/glove. All passed acceptance criteria of 2 Mg/Glove Max.
- Permeation Test Result as per ASTM D6978 for various chemotherapy drugs and Fentanyl Citrate. Most tested chemotherapy drugs showed a minimum breakthrough detection time of >240 Minutes, except for Carmustine (35.0 Minutes) and Thiotepa (64.9 Minutes). Fentanyl Citrate also showed >240 Minutes. All showed slight swelling & no degradation.
- Non-Clinical Testing Bio-Compatibility Data:
- ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done for irritation: Under the condition of study not an irritant. Acceptance Criteria: Non irritant.
- ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done Skin sensitization: Under the conditions of the study not a sensitizer. Acceptance Criteria: Non sensitizer.
- ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity: Under the conditions of the study cytotoxic. Acceptance Criteria: Non cytotoxic.
- ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity: Under the conditions of study the device extracts do not pose acute systemic toxicity concern. Acceptance Criteria: Not pose systemic toxicity concern.
- Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. Acceptance Criteria: Not pose material mediated pyrogenicity response.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Applicable
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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 7, 2022
JR Engineering & Medical Technologies (M) SDN. BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. Ste 114 Aurora, Illinois 60504
Re: K221626
Trade/Device Name: Jr Medic Blue Nitrile Examination Gloves Powder Free 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, QDO Dated: November 10, 2022 Received: November 14, 2022
Dear Manoj Zacharias:
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 medical devices and radiation-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) K221626
Device Name
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
Indications for Use (Describe)
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|---|---|
| Bendamustine (5 mg/ml) | >240 Minutes |
| Bleomycin (15 mg/ml) | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes |
| Carfilzomib (2 mg/ml) | >240 Minutes |
| Cetuximab (2 mg/ml) | >240 Minutes |
| Cladribine (1 mg/ml) | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes |
| Decitabine (5 mg/ml) | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes |
| Fulvestrant (50 mg/ml) | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes |
| Mechlorethamine (1 mg/ml) | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes |
| Oxaliplatin (5 mg/ml) | >240 Minutes |
| Paraplatin (10 mg/ml) | >240 Minutes |
| Pemetrexed (25 mg/ml) | >240 Minutes |
| Raltitrexed (0.5 mg/ml) | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes |
| Topotecan (1 mg/ml) | >240 Minutes |
| Triclosan (2 mg/ml) | >240 Minutes |
| Trisenox (1 mg/ml) | >240 Minutes |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes |
| Vinblastine (1 mg/ml) | >240 Minutes |
| Vinorelbine (10 mg/ml) | >240 Minutes |
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
3
| Cisplatin (1 mg/ml) | >240 Minutes |
|---|---|
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml)
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes
Warning: Do not use with Carmustine or Thiotepa.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) SUMMARY K221626 As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION
| 510(K) Owner's Name | JR Engineering & Medical Technologies (M) Sdn. Bhd. |
|---|---|
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, |
| Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor | |
| Darul Ehsan, Malaysia. | |
| Phone | +603-60572081 |
| Fax | +603-60572181 |
| ganeshjrmt@gmail.com | |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | +6012 224 6677 |
| Contact Email | ganeshjrmt@gmail.com |
| Date Submitted | 10th November 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Jr Medic Blue Nitrile Examination Gloves Powder Free
tested for use with Chemotherapy drugs and Fentanyl
Citrate |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty &
Fentanyl and other opioid protection glove |
| Device Classification | Class-1 |
| Product Code | LZA, LZC, QDO, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Halyard Lavender Nitrile, Powder-free Exam Gloves
Tested for use with Chemotherapy Drugs and Fentanyl
Citrate |
|------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K202622 |
| Regulatory Class | 1 |
| Product code | LZC, QDO |
D. DESCRIPTION OF THEDEVICE:
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is
5
available in Small, Medium, Large and Extra Large sizes.
The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
E. INTENDED USE OF THE DEVICE/INDICATIONS FOR USE:
Ir Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
| Tested Chemotherapy Drug Name & | Minimum Breakthrough Detection |
|---|---|
| Concentration | Time (Minutes) |
| Bendamustine (5 mg/ml) | >240 Minutes |
| Bleomycin (15 mg/ml) | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes |
| Carfilzomib (2 mg/ml) | >240 Minutes |
| Cetuximab (2 mg/ml) | >240 Minutes |
| Cladribine (1 mg/ml) | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes |
| Decitabine (5 mg/ml) | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes |
| Fulvestrant (50 mg/ml) | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes |
| Mechlorethamine (1 mg/ml) | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes |
| Oxaliplatin (5 mg/ml) | >240 Minutes |
| Paraplatin (10 mg/ml) | >240 Minutes |
| Pemetrexed (25 mg/ml) | >240 Minutes |
| Raltitrexed (0.5 mg/ml) | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes |
| Topotecan (1 mg/ml) | >240 Minutes |
| Triclosan (2 mg/ml) | >240 Minutes |
| Trisenox (1 mg/ml) | >240 Minutes |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
6
| Vinblastine (1 mg/ml) | >240 Minutes |
|---|---|
| Vinorelbine (10 mg/ml) | >240 Minutes |
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml)
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes
Warning: Do not use with Carmustine (BCNU) & Thiotepa
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATE | PROPOSED DEVICE | |||
| 510(K) Number | - | K202622 | K221626 | |
| Name of device | Halyard Lavender | |||
| Nitrile, Powder- | ||||
| free Exam Gloves | ||||
| Tested for use | ||||
| with | ||||
| Chemotherapy | ||||
| Drugs and | ||||
| Fentanyl Citrate | Jr Medic | |||
| Blue Nitrile | ||||
| Examination Gloves | ||||
| Powder Free tested | ||||
| for use with | ||||
| Chemotherapy drugs | ||||
| and Fentanyl Citrate | Similar | |||
| Product Code | - | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Similar |
| Intended use / | ||||
| Indications for Use | The Halyard | |||
| Lavender Nitrile, | ||||
| Powder-free Exam | ||||
| Gloves | ||||
| Tested for use | ||||
| with | ||||
| Chemotherapy | ||||
| Drugs and | Jr Medic Blue Nitrile | |||
| Examination Gloves | ||||
| Powder Free tested | ||||
| for use with | ||||
| Chemotherapy drugs | ||||
| and Fentanyl Citrate | ||||
| is a disposable device | ||||
| intended for medical | Similar |
7
| | | Fentanyl Citrate
are disposable | purpose that is worn
on the examiner's | |
| -- | -- | ------------------------------------ | ------------------------------------------- | -- |
|---|
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATE | ||||
| K202622 | PROPOSED | |||
| DEVICE | ||||
| device intended | ||||
| for medical | ||||
| purpose that is | ||||
| worn on the | ||||
| examiner's hand | ||||
| to prevent | ||||
| contamination | ||||
| between patient | ||||
| and examiner. | ||||
| The gloves were | ||||
| tested for use | ||||
| with the | ||||
| chemotherapy | ||||
| drugs and | ||||
| Fentanyl Citrate | ||||
| as per ASTM D | ||||
| 6978-05 | hand to prevent | |||
| contamination | ||||
| between patient | ||||
| and examiner. | ||||
| Additionally, the | ||||
| gloves were tested | ||||
| for use with | ||||
| chemotherapy | ||||
| drugs and | ||||
| Fentanyl Citrate in | ||||
| accordance with | ||||
| ASTM D6978-05 | ||||
| (2019) Standard | ||||
| Practice for | ||||
| Assessment of | ||||
| Medical Glove to | ||||
| Permeation by | ||||
| Chemotherapy | ||||
| Drugs. | ||||
| Regulation Number | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | - | Nitrile | Nitrile | Same |
| Color | - | Lavender | Blue | Different |
| Size | ASTM D6319- | |||
| 2019 | Extra Small, | |||
| Small, Medium, | ||||
| Large, Extra Large | Small, Medium, | |||
| Large, Extra Large | Similar | |||
| Single Use | Medical Glove | |||
| Guidance | ||||
| Manual |
- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-
2019 | Length:
295-325 mm
Width
XS- 60-80mm
S- 70-90mm
M- 85-105mm
L- 100-120mm
XL- 110-130mm | Length > 230 mm
Width Min 95+/-
10 mm(for
medium size) | Similar |
| CHARACTE
RSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
| | | PREDICATE DEVICE
K202622 | PROPOSED DEVICE
K221626 | |
| Physical
Properties | ASTM D6319-2019 | Before Ageing
Tensile Strength
$\ge$ 14 Mpa
Ultimate Elongation
$\ge$ 500%
After Ageing
Tensile Strength
$\ge$ 14 Mpa
Ultimate Elongation
$\ge$ 400% | Before Ageing
Tensile Strength
14 Mpa
Ultimate Elongation
500%
After Ageing
Tensile Strength
14 Mpa
Ultimate Elongation
400% | Similar |
| Thickness | ASTM D6319-2019 | Palm
0.10-0.16 mm
Finger
0.10-0.19 mm | Palm >0.05 mm
Finger > 0.05 mm | Similar |
| Powder Free
Residue | ASTM D6319-2019 | $\le$ 2 mg/glove | $\le$ 2 mg/glove | Similar |
| Watertight
(1000 ml) | ASTM D5151-2019 | Passes AQL-2.5 | Passes AQL-1.5 | Similar |
| Label and
Labeling | FDA Label
requirements | Meets FDA's
requirements | Meets FDA's
requirements | Same |
| Bio-
compatibility | Primary Skin
Irritation-ISO 10993-
10:2010
(E) | Under the condition of
study the device
extracts were not found
to cause a systemic
response in the animal
model. | Under the condition
of study not an
irritant | Similar |
| | Dermal Sensitization-
ISO 10993-10:2010
(E) | No Data Available | Under the conditions
of the study not a
sensitizer | ---- |
| | In vitro
cytotoxicity
ISO10993-5 :2009(E) | No Data Available | Under the
conditions of the
study, cytotoxic | ---- |
| | Material
Mediated
Pyrogenicity
ISO 10993-
11:2017(E) /
USP 41 | No Data Available | Under the
conditions of
the study no
material-
mediated
pyrogenic | ---- |
| | Acute Systemic
Toxicity Test ISO
10993-11:2017(E) | Under the conditions of
the study, the test
article was considered
non toxic | Under the condition
of study does not
induce any systemic
toxic concern | Similar |
8
9
| Chemotherapy Drugs tested with Minimum Breakthrough Detection Time as tested per ASTM | ||||
|---|---|---|---|---|
| D6978-05 (2019) | ||||
| Bendamustine (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Bleomycin (15 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Busulfan (6 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Carfilzomib (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cetuximab (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cladribine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cytarabine (100 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Decitabine (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Docetaxel (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fludarabine (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fulvestrant (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Gemcitabine (38 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Irinotecan (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Mechlorethamine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Melphalan (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Oxaliplatin (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Paraplatin (10 mg/ml) | Not Tested | >240 Minutes | Different | |
| Pemetrexed (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Raltitrexed (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Rituximab (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Topotecan (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Triclosan (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Trisenox (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vinblastine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vinorelbine (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Capecitabine (26 mg/ml) | >240 Minutes | Not Tested | Different | |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Dacarbazine (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Dactinomycin (0.5 mg/ml) | >240 Minutes | Not Tested | Different | |
| Doxorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| 5-Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes | Same |
10
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes | Same |
|---|---|---|---|
| Leuprolide Acetate Salt ( 5 | |||
| mg/ml) | >240 Minutes | Not Tested | Different |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Temsirolimus (25 mg/ml) | >240 Minutes | Not Tested | Different |
| Vincristine (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Zoledronic Acid (0.8 mg/ml) | >240 Minutes | Not Tested | Different |
| Carmustine (3.3 mg/ml) | 0.3 Minutes | 35.0 Minutes | Different |
| Thiotepa (10 mg/ml) | 30.9 Minutes | 64.9 Minutes | Different |
Hazardous Drugs (opioid) tested with Minimum Breakthrough Detection Time as tested per ASTM D6978-05 (2019)
| Fentanyl Citrate (100 mg/ml) | >240 Minutes | >240 Minutes | Same |
|---|---|---|---|
| ------------------------------ | -------------- | -------------- | ------ |
There are no significant differences between the proposed device and the predicate device and are identical in terms of intended use, materials, design, manufacturing methods & resistance of medical gloves to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978- 05(2019).
G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 | |||
| Standard Specification for | |||
| Nitrile Examination Gloves | |||
| for Medical Application | To determine the length | ||
| of the gloves | Min 220 mm for Size | ||
| Small & Min 230 mm | |||
| for all other sizes | Small:- 404 mm | ||
| Medium:- 405 mm | |||
| Large:- 405 mm | |||
| X-Large:- 406 mm |
11
| Test Method | Purpose | Acceptance Criteria | Result | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-2019 Standard | ||||||||||||||||||
| Specification for Nitrile | ||||||||||||||||||
| Examination Gloves for | ||||||||||||||||||
| Medical Application | To determine the | |||||||||||||||||
| width of the gloves | Small:- $80+/-10$ mm | |||||||||||||||||
| Medium:- $95+/-10$ mm | ||||||||||||||||||
| Large:- $110+/-10$ mm | ||||||||||||||||||
| X-Large:- $120+/10$ mm | Small:- 84 mm | |||||||||||||||||
| Medium:- 94 mm | ||||||||||||||||||
| Large:- 105 mm | ||||||||||||||||||
| X-Large:- 115 mm | ||||||||||||||||||
| ASTM D6319-2019 Standard | ||||||||||||||||||
| Specification for Nitrile | ||||||||||||||||||
| Examination Gloves for | ||||||||||||||||||
| Medical Application | To determine the | |||||||||||||||||
| thickness of the | ||||||||||||||||||
| gloves | Palm 0.05 mm min | |||||||||||||||||
| Finger 0.05 mm min | ||||||||||||||||||
| for all sizes | Size Palm Finger Small 0.19mm 0.21mm Medium 0.19mm 0.21mm Large 0.19mm 0.21mm X-Large 0.19mm 0.21mm | |||||||||||||||||
| To Determine the | ||||||||||||||||||
| physical properties- | ||||||||||||||||||
| Tensile strength | Before Ageing | |||||||||||||||||
| Tensile Strength | ||||||||||||||||||
| 14Mpa Min for all | ||||||||||||||||||
| sizes | Size Before | |||||||||||||||||
| ageing After | ||||||||||||||||||
| ageing Small 22.77Mpa 20.50Mpa Medium 24.46Mpa 21.81Mpa Large 24.51Mpa 21.95Mpa X-Large 24.59Mpa 22.05Mpa | ||||||||||||||||||
| After Ageing Tensile | ||||||||||||||||||
| Strength 14Mpa Min | ||||||||||||||||||
| for all sizes | ||||||||||||||||||
| ASTM D6319-2019 Standard | ||||||||||||||||||
| Specification for Nitrile | ||||||||||||||||||
| Examination Gloves for | ||||||||||||||||||
| Medical Application | To Determine the | |||||||||||||||||
| physical properties- | ||||||||||||||||||
| Ultimate Elongation | Before Ageing | |||||||||||||||||
| Ultimate Elongation | ||||||||||||||||||
| 500% Min for all | ||||||||||||||||||
| sizes | Size Before | |||||||||||||||||
| ageing After | ||||||||||||||||||
| ageing Small 885% 868% Medium 888% 870% Large 891% 872% X-Large 892% 875% | ||||||||||||||||||
| After Ageing | ||||||||||||||||||
| Ultimate Elongation | ||||||||||||||||||
| 400% Min for all | ||||||||||||||||||
| sizes |
| Test Method | Purpose | Acceptance
Criteria | Result |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------|
| ASTM D5151-2019 Standard
Test Method for Detection of
Holes in Medical Gloves | To determine the
holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved
2017) Standard Test Method
for Residual Powder on
Medical Gloves | To determine the
residual powder in
the gloves | 2 Mg/Glove Max | Size
Small 0.16 mg/glove
Medium 0.16 mg/glove
Large 0.16 mg/glove
X-Large 0.16mg/glove |
12
PERMEATION TEST RESULT AS PER ASTM D6978
| Test Chemotherapy Drugs | Minimum
Breakthrough
Detection Time
(Minutes) | Avg. Steady
State
Perm. Rate
(µg/cm²/Minute) | Other Observations |
|------------------------------------|--------------------------------------------------------|-------------------------------------------------------|----------------------------------|
| Bendamustine (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Bleomycin (15 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Busulfan (6 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carfilzomib (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cetuximab (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cladribine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cytarabine (100 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Decitabine (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Docetaxel (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Fludarabine (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Fulvestrant (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Gemcitabine (38 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Irinotecan (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mechlorethamine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Melphalan (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Oxaliplatin (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Paraplatin (10 mg/ml) | Not Tested | NA | Slight swelling & no degradation |
| Pemetrexed (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Raltitrexed (0.5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Rituximab (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Topotecan (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Triclosan (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Trisenox (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Velcade (Bortezomib)
(1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vidaza (Azacytidine)
(25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vinblastine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vinorelbine (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carboplatin (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cisplatin (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Dacarbazine (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Doxorubicin HCl (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Etoposide (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| 5-Fluorouracil (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Ifosfamide (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Test Chemotherapy Drugs | Minimum
Breakthrough
Detection Time
(Minutes) | Avg. Steady
State
Perm. Rate
(µg/cm²/Minute) | Other Observations |
| Methotrexate (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mitoxantrone (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Paclitaxel (6 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vincristine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carmustine (3.3 mg/ml) | 35.0 Minutes | NA | Slight swelling & no degradation |
| Thiotepa (10 mg/ml) | 64.9 Minutes | NA | Slight swelling & no degradation |
13
H. NON- CLINICAL TESTING BIO-COMPATABILITY DATA
| Test Method | Purpose | Acceptance
Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done for
irritation. | To determine the potential of
the material under test to
produce dermal irritation in
Rabbits | Non irritant | Under the condition of
study not an irritant |
| ISO 10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done Skin
sensitization. | To determine the skin
sensitization potential of the
material both in terms of
induction and elicitation in
Guinea Pig. | Non sensitizer | Under the conditions of
the study not a
sensitizer |
| ISO 10993-5:2009 biological
evaluation of medical devices -
part 5, tests for in vitro
cytotoxicity. | To evaluate the in vitro
cytotoxic potential of the test
item (both inner and outer
surface) Extracts in L-929
mouse fibroblasts cells using
elution method. | Non cytotoxic | Under the conditions of
the study cytotoxic. |
| ISO 10993-11:2017 biological
evaluation of medical devices -
part 11, tests for systemic
toxicity. | To determine the acute
systemic toxicity potential of
the test item extracts (both
inside and outer surfaces) in
Swiss Albino mice. | Not pose systemic
toxicity concern | Under the conditions
of study the device
extracts do not pose
acute systemic
toxicity concern |
| Material
Mediated
Pyrogenicity ISO 10993-
11:2017(E) / USP 41 | To determine the pyrogenic
potential of the test item
extract following intravenous
injection in New Zealand
white Rabbits. | Not pose material
mediated
pyrogenicity
response | Under the conditions of
the study, the device did
not demonstrate a
material mediated
pyrogenicity response. |
14
I. Clinical Testing Summary
No clinical information is included in this submission
J. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.