(265 days)
Not Found
No
The document describes a standard examination glove and its performance characteristics, with no mention of AI or ML technologies.
No
The device is a medical glove, functioning as a barrier to prevent contamination, not to treat or cure a disease or condition.
No
This device is a patient examination glove, intended to provide barrier protection between the patient and examiner, not to diagnose medical conditions.
No
The device is a physical examination glove made from nitrile compound, which is a hardware component. The summary describes bench testing of physical properties and performance characteristics, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or fingers to prevent contamination between patient and examiner. This is a physical barrier function.
- Device Description: The description reinforces its function as a "single use barrier protection for the wearer."
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Testing: The testing described focuses on the physical properties of the glove (dimensions, tensile strength, water leak, powder residual, biocompatibility) and its resistance to chemotherapy drugs. These are all related to its barrier and protective function, not diagnostic capabilities.
- Key Metrics: The key metrics measured are related to the glove's physical integrity and resistance to chemicals, not diagnostic performance metrics like sensitivity, specificity, or AUC.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide diagnostic information. This glove does not perform any such testing.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Product codes
LZA, LZC
Device Description
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color and Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color are a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs made by Syntex Healthcare Products Co., Ltd. met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing:
- Dimension per ASTM D6319-10 (Reapproved 2015) A
- Tensile strength (Before aging/After aging) and Elongation (Before aging/After aging) per ASTM D6319-10(Reapproved 2015)
- Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20.
- A Powder Residual tests per ASTM D6319-10(Reapproved 2015)
- Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
- Assessment Of Resistance To Permeation By Chemotherapy Drugs per ASTM D6978-05(R 2013)
Clinical data was not needed to demonstrate that the substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2019
Ever Growth (Vietnam) Co. Ltd. % Elizabeth Deng U.S. Representative Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California 91730
Re: K190860
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 30, 2019 Received: September 30, 2019
Dear Elizabeth Deng:
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 (OS) 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.
For Elizabeth Claverie, M.S. 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) K190860
Device Name
Thiotepa
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Test Chemotherapy Drug | Concentration(mg/ml) | Minimum Breakthrough Detection Time ( Min) |
|---|---|---|
| 1 Carmustine (BCNU), | 3.3 mg/ml | 11.8 |
| 2 Thiotepa, | 10.0 mg/ml | 16.9 |
| 3 Cyclophosphamide (Cytoxan), | 20.0 mg/ml | >240 |
| 4 Cisplatin, | 1.0 mg/ml | >240 |
| 5 Doxorubicin Hydrochloride, | 2.0 mg/ml | >240 |
| 6 Fluorouracil, | 50.0 mg/ml | >240 |
| 7 Dacarbazine (DTIC), | 10.0 mg/ml | >240 |
| 8 Etoposide (Toposar), | 20.0 mg/ml | >240 |
| 9 Paclitaxel (Taxol), | 6.0 mg/ml | >240 |
Warning: Please do not use with Carmustine (BCNU) and Thiotepa
10.0 mg/ml
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.
16.9 minutes
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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Indications for Use
510(k) Number (if known) K190860
Device Name
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Test Chemotherapy Drug | Concentration(mg/ml) | Minimum Breakthrough Detection Time ( Min) |
|---|---|---|
| 1 Carmustine (BCNU), | 3.3 mg/ml | 31.6 |
| 2 Thiotepa, | 10.0 mg/ml | 72.5 |
| 3 Cyclophosphamide (Cytoxan), | 20.0 mg/ml | >240 |
| 4 Cisplatin, | 1.0 mg/ml | >240 |
| 5 Doxorubicin Hydrochloride, | 2.0 mg/ml | >240 |
| 6 Fluorouracil, | 50.0 mg/ml | >240 |
| 7 Dacarbazine (DTIC), | 10.0 mg/ml | >240 |
| 8 Etoposide (Toposar), | 20.0 mg/ml | >240 |
| 9 Paclitaxel (Taxol), | 6.0 mg/ml | >240 |
| The maximum testing time is 240 minutes. |
Please note that the following drug has an extremely low permeation time:
| Carmustine (BCNU) | 3.3 mg/ml | 31.6 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml | 72.5 minutes |
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."
Form Approved: OMB No. 0910-0120
4
510(k) Summary
K190860
| 1.0 Submitter: | Submitter's name : | Ever Growth (Vietnam) Co., Ltd. |
|---|---|---|
| Submitter's address : | Long Khanh Industrial Zone, Binh Loc Ward, Long Khanh Township, Dong Nai | |
| Vietnam | ||
| Phone number : | 84-61-3514025 | |
| Fax number : | 84 -61-3514023 | |
| Name of contact person: | Ming Lee | |
| Summary Preparation Date: | Nov. 26th, 2019 | |
| 2.0 US Agent: | US representative name | Elizabeth Deng |
| Company address | 5748 Eaglewood Place | |
| Rancho Cucamonga, California | ||
| Rancho Cucamonga, CA 91739 | ||
| Telephone number | 909 4659188 | |
| Contact email | Baxianunited48@Yahoo.Com | |
| 3.0 Name of the Device | Proprietary/Trade name: | Disposable Powder Free Nitrile Examination Glove, Tested For Use With |
| Chemotherapy Drugs, White Color | ||
| Disposable Powder Free Nitrile Examination Glove, Tested For Use With | ||
| Chemotherapy Drugs, Orange Color | ||
| Common Name: | Nitrile Examination Gloves | |
| 510(k) Number | K190860 | |
| Classification Name: | Patient Examination Glove | |
| Device Classification: | Class I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Product Code: | LZA, LZC | |
| 4.0 Predicate device | Device Name: | Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with |
| Chemotherapy Drugs | ||
| Company name: | Syntex Healthcare Products Co., Ltd | |
| 510(K) Number: | K182156 | |
| 5.0 Device Description: |
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color and Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color are a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
6.0 Indications for Use:
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color
A patient examination gloves is a disposable device intended for medical purpose that is worn on the
examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves
5
were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) | |
|---|---|---|
| 1 | Carmustine (BCNU), 3.3 mg/ml | 11.8 |
| 2 | Thiotepa, 10.0 mg/ml | 16.9 |
| 3 | Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 |
| 4 | Cisplatin, 1.0 mg/ml | >240 |
| 5 | Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| 6 | Fluorouracil, 50.0 mg/ml | >240 |
| 7 | Dacarbazine (DTIC), 10.0 mg/ml | >240 |
| 8 | Etoposide (Toposar), 20.0 mg/ml | >240 |
| 9 | Paclitaxel (Taxol), 6.0 mg/ml | >240 |
Table 6.1 Nitrile White color test for 7+2 chemotherapy drugs
The maximum testing time is 240 minutes.
Please note that the following drug has an extremely low permeation time:
| Carmustine (BCNU), 3.3 mg/ml | 11.8 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 16.9 minutes |
Warning: Please do not use with Carmustine (BCNU) and Thiotepa
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) | |
|---|---|---|
| 1 | Carmustine (BCNU), 3.3 mg/ml | 31.6 |
| 2 | Thiotepa, 10.0 mg/ml | 72.5 |
| 3 | Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 |
| 4 | Cisplatin, 1.0 mg/ml | >240 |
| 5 | Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| 6 | Fluorouracil, 50.0 mg/ml | >240 |
| 7 | Dacarbazine (DTIC), 10.0 mg/ml | >240 |
| 8 | Etoposide (Toposar), 20.0 mg/ml | >240 |
| 9 | Paclitaxel (Taxol), 6.0 mg/ml | >240 |
Table 6.2 Nitrile Orange color test for 7+2 chemotherapy drugs
The maximum testing time is 240 minutes.
Please note that the following drug has an extremely low permeation time:
6
| Carmustine (BCNU), 3.3 mg/ml | 31.6 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 72.5 minutes |
7.0 Summary of the Technological Characteristics of the Device:
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color and Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color are summarized with the following technological characteristics compared to ASTM or equivalent standard. Table 5.3 Summary of the Technological Characteristics
| Characteristics | Standard | |
|---|---|---|
| Dimension | Length | ≥230mm |
| Width | ||
| X Small | 70 ± 10 mm | |
| Small | 80 ± 10 mm | |
| Medium | 95 ± 10 mm | |
| Large | 110 ± 10 mm | |
| X large | 120 ± 10 mm | |
| Thickness | ||
| Finger tip | ≥0.05mm | |
| Palm | ≥0.05mm | |
| Physical Properties | ASTM standard D 6319-10(Reapproved 2015) | |
| Tensile strength (Before aging) | ≥14MPa | |
| Tensile strength (After aging) | ≥14MPa | |
| Elongated rate (Before aging) | ≥500% | |
| Elongated rate (After aging) | ≥400% | |
| Freedom from pinholes | 21 CFR 800.20 | |
| Passed Standard Acceptance Criteria | ||
| ASTM standard D 6319-10 (Reapproved 2015) | ||
| Test method in accordance with ASTM | ||
| D5151-06(Reapproved 2015) | ||
| Powder Residual | ASTM standard D6319-10(Reapproved 2015) | |
| Test method in accordance with | ||
| D6124-06(Reaffirmation 2011) | ||
| Tensile strength (Before aging/After aging) and Elongation (Before aging/After aging) per ASTM D6319-10(Reapproved 2015) |
7
-
Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20.
- A Powder Residual tests per ASTM D6319-10(Reapproved 2015)
-
Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
-
Assessment Of Resistance To Permeation By Chemotherapy Drugs per ASTM D6978-05(R 2013)
9.0 Based on Assessment of Clinical Performance Data:
Clinical data was not needed to demonstrate that the substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.
10.0 Substantial Equivalence Comparison:
| Table 5.4 SE compare | ||||
|---|---|---|---|---|
| ---------------------- | -- | -- | -- | -- |
| Device
| Characteristic | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Product name | Powder-Free Nitrile Examination Gloves | ||
| (Blue), Tested for Use with | |||
| Chemotherapy Drugs | Disposable Powder Free Nitrile | ||
| Examination Glove, Tested For Use With | |||
| Chemotherapy Drugs, White Color |
Disposable Powder Free Nitrile
Examination Glove, Tested For Use With
Chemotherapy Drugs, Orange Color | N/A |
| 510(K) No. | K182156 | K190860 | N/A |
| Product Owner | Syntex Healthcare Products Co., Ltd | Ever Growth Enterprise Corporation | Different |
| Product Code | LZA, LZC | LZA, LZC | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | | | same |
| Intended Use | The Nitrile Powder Free Examination
Glove (Blue) with Low Dermatitis
Potential Claim is a disposable device
intended for medical purpose that is
worn on the examiner's hands or finger
to prevent contamination between
patient and examiner. In addition these
gloves were tested for use with
Chemotherapy drugs in accordance
with ASTM D6978-05 standards Practice
for assessment of Medical Glove to
Permeation by chemotherapy drugs. | A patient examination gloves is a
disposable device intended for medical
purpose that is worn on the examiner's
hand or fingers to prevent contamination
between patient and examiner. In addition,
these gloves were tested for use with
chemotherapy drugs in accordance with
ASTM D6978-05 Standard Practice for
Assessment of Medical gloves to
Permeation by Chemotherapy Drugs. | similar |
| Power free | Yes | Yes | same |
| Size | X Small/Small/ Medium/Large/X Large | X Small/ Small/ Medium/Large/X Large | similar |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | same |
| Dimensions-
Length | Complies with ASTM D6319-10
230 mm min. | Complies with ASTM D6319-10
230 mm min. | same |
| Dimensions | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
8
| -Palm Width | X Small | $70\pm10$ | X Small | $70\pm10$ | |
|---|---|---|---|---|---|
| Small | $80\pm10$ | Small | $80\pm10$ | ||
| Medium | $95\pm10$ | Medium | $95\pm10$ | ||
| Large | $110\pm10$ | Large | $110\pm10$ | ||
| X large | $120\pm10$ | X large | $120\pm10$ | ||
| Dimensions | |||||
| -Thickness | Complies with ASTM D6319-10 | ||||
| Palm - 0.05 mm min. | |||||
| Finger - 0.05 mm min. | Complies with ASTM D6319-10 | ||||
| Palm - 0.05 mm min. | |||||
| Finger - 0.05 mm min. | similar | ||||
| Physical | |||||
| Properties | Tensile Strength: | ||||
| Before Aging 14 MPa, min. | |||||
| After Aging 14 MPa, min. |
Elongation:
Before Aging 500% min.
After Aging 400% min. | | Tensile Strength:
Before Aging 14 MPa, min.
After Aging 14 MPa, min.
Elongation:
Before Aging 500% min.
After Aging 400% min. | | same |
| Residual
powder | Complies with ASTM D6319-10
240 | >240 | >240 | same |
| Cisplatin, 1.0 mg/ml | | >240 | >240 | >240 | same |
| | Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 | >240 | same |
| Fluorouracil, 50.0 mg/ml | | >240 | >240 | >240 | same |
| Dacarbazine (DTIC), 10.0 mg/ml | | >240 | >240 | >240 | same |
| Etoposide (Toposar), 20.0 mg/ml | | >240 | >240 | >240 | same |
| Paclitaxel (Taxol), 6.0 mg/ml | | >240 | >240 | >240 | same |
11.0 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.