(86 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technologies.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
The device, a patient examination glove, is intended to prevent contamination and is tested for resistance to chemotherapy drugs and fentanyl, not to diagnose a medical condition.
No
The device described is a physical medical device (examination gloves) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Intended Use: The intended use of this device is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device used externally during medical procedures.
- No Specimen Examination: The device does not involve the collection, preparation, or examination of any human specimens.
- Testing for Permeation: While the device is tested for resistance to chemotherapy drugs and Fentanyl permeation, this testing is related to the protective barrier function of the glove, not to the diagnosis or monitoring of a patient's condition through the analysis of a specimen.
The testing for chemotherapy drug and Fentanyl permeation is a performance characteristic of the glove as a protective barrier, not an indication that it is used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
The following chemotherapy drugs have been tested with the glove:
Carmustine: 3.3 mg/ml
Cisplatin: 1.0 mg/ml
Cyclophosphamide: 20.0 mg/ml
Dacarbazine: 10.0 mg/ml
Doxorubicin HCL: 2.0 mg/ml
Etoposide: 20.0 mg/ml
Fluorouracil: 50.0 mg/ml
Methotrexate: 25.0 mg/ml
Paclitaxel: 6.0 mg/ml
ThioTepa: 10.0 mg/ml
Mitomycin C: 0.5 mg/ml
Vincristine Sulfate: 1.0 mg/ml
Fentanyl Citrate: 100 mcg/2mL
Warning: Do not use with Carmustine and ThioTepa.
A Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand, in order to prevent contamination between patient and examiner, and also prevent transmission of a wide variety of diseases to both patient and health care personnel. In addition, these gloves were tested for chemotherapy drug permeation test.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex. General specifications of the glove are as below:
- Overall Length: 230 mm minimum
- Width: 95 ± 5 mm minimum (for medium glove)
- Palm Thickness: 0.05 mm minimum
- Finger Thickness: 0.05 mm minimum
- Tensile Strength:
a. Before Aging: 14 MPa minimum
b. After Aging: 14 MPa minimum - Ultimate Elongation:
a. Before Aging: 500 % minimum
b. After Aging: 400 % minimum - Pinhole AQL: 2.5
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 purposes, Health care personnel
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:
- Dimension Test: To evaluate whether the device meets the current ASTM D6319-19. Result: Meets requirement.
- Freedom From Hole: To evaluate whether the subject meets current 21 CFR 800.20, ASTM D6319-19 and test according to ASTM D5151-19. Result: Meets requirements.
- Physical Property Test: To evaluate whether the subjects meet current ASTM D6319-19 and test according to ASTM D412 and ASTM D573. Result: Meets requirement.
- Residual Powder Test: To evaluate whether the subjects meet current ASTM D6319-19 and test according to ASTM D6124-06. Result: Meets requirement.
- Biocompatibility Test (Skin Irritation): To determine whether skin irritation potential of device meets ISO 10993-10. Result: Non-irritant under the conditions of the study.
- Biocompatibility Test (Skin Sensitization): To determine whether skin sensitization potential of device meets ISO 10993-10. Result: Non-sensitizer under the conditions of the study.
- Biocompatibility Test (Acute Systemic Toxicity): To determine whether leachable extracted from the device would cause acute systemic toxicity and meet ISO 10993-11. Result: Not an acute systemic toxic under the condition of the study.
- Chemotherapy drug permeation test (ASTM D6978-05) was conducted. The results for the proposed device are summarized in Table 5.1 and Table 6.3, showing breakthrough detection times for various chemotherapy drugs and Fentanyl Citrate. The predicate device's permeation results are also provided for comparison. It is noted that Carmustine and ThioTepa have extremely low permeation times, and a warning is issued not to use the gloves with these two drugs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include physical properties (tensile strength, ultimate elongation), pinhole AQL, and resistance to permeation by chemotherapy drugs, reported as Minimum Breakthrough Detection Time in minutes.
- Tensile Strength: Before Aging (14 MPa minimum), After Aging (14 MPa minimum)
- Ultimate Elongation: Before Aging (500 % minimum), After Aging (400 % minimum)
- Pinhole AQL: 2.5
- Residual Powder:
§ 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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
May 27, 2022
Encompass Industries Sdn. Bhd. Nur Muhyiddin OA Manager Lot 18256, Kawasan Perindustrian Lot Q Kertih BioPolymer Park Kemaman, Terengganu 24300 Malaysia
Re: K220609
Trade/Device Name: Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: February 24, 2022 Received: March 2, 2022
Dear Nur Muhyiddin:
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, M.D., Ph.D. Acting 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) K220609
Device Name
Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
The following chemotherapy drugs have been tested with the glove:
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes | ||||
|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | ||
| Carmustine | 3.3 mg/ml | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| ThioTepa | 10.0 mg/ml | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100 mcg/2mL | >240 | >240 | >240 | >240 | >240 |
*Please note that the following 2 drugs have extremely low permeation times:
-
- Carmustine
-
- Thiotepa
Warning: Do not use with Carmustine and ThioTepa.
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.
3
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4
510(k) Summary
K220609
Preparation date: May 27, 2022
| 1. Submitter | ||
|---|---|---|
| Name | : | Encompass Industries Sdn. Bhd. |
| Address | : | Lot 18256, Kawasan Perindustrian Lot Q, |
| Kertih Bio-Polymer Park, 24300 Kemaman, | ||
| Terengganu, Malaysia. | ||
| Telephone No. | : | +609 831 8866 |
| Contact Person | : | Nur Atikah binti Muhammad Muhyiddin |
| : | regulatory@encompass-medical.com atikah@ems-inc.com |
2. Identification of Device
| Trade/Proprietary Name(s) | : 1. Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl
2. Other clients' trade name and private labeling |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name(s) | : Powder-Free Nitrile Examination Glove |
| Classification Name: | : 1. Non-powdered Patient Examination Glove (21 CFR 880.6250)
2. Patient Examination Glove, Specialty (Product Code: LZC)
3. Polymer Patient Examination Glove (Product Code: LZA) |
| Device Classification | : Class I |
3. Identification of Legally Marketed Device as Predicate
| Predicate name | : Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile,
Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | : K200181 |
| Company | : Comfort Rubber Glove Industries Sdn Bhd |
4. Description of Device
The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex. General specifications of the glove are as below:
| 1. Overall Length | : | 230 mm minimum |
|---|---|---|
| 2. Width | : | 95 ± 5 mm minimum (for medium glove) |
| 3. Palm Thickness | : | 0.05 mm minimum |
| 4. Finger Thickness | : | 0.05 mm minimum |
| 5. Tensile Strength | ||
| a. Before Aging | : | 14 MPa minimum |
5
| b. After Aging | : | 14 MPa minimum |
|---|---|---|
| 6. Ultimate Elongation | ||
| a. Before Aging | : | 500 % minimum |
| b. After Aging | : | 400 % minimum |
| 7. Pinhole AQL | : | 2.5 |
5. Intended Use / Indication for Use:
A Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for chemotherapy drugs permeation test.
Table 5.1 Summary Test Results for Resistance of Powder-Free Nitrile Examination Gloves (White, Blue, Black, Orange and Green Color) to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time (minutes) | ||||
|---|---|---|---|---|---|---|
| White | Blue | Black | Orange | Green | ||
| Carmustine (BCNU)* | 3.3 mg/ml | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| ThioTepa* | 10.0 mg/mL | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100.0 mcg/2mL | >240 | >240 | >240 | >240 | >240 |
| *Please note that the following drugs have extremely low permeation time: | ||||||
| 1. Carmustine (3.3 mg/mL) |
- Thiotepa (10 mg/mL)
Warning: Do not use with Carmustine and ThioTepa.
6. Comparative Technological Characteristics & Performance Information Summary
Table 6.1 Summary of Technological Characteristics Comparison between Proposed Device and Predicate Device
| Device Performance / Characteristic | Comparison Analysis | ||||
|---|---|---|---|---|---|
| Character- | |||||
| istics | Requirement / | ||||
| Standard | Predicate Device | ||||
| (K200181) | Subject Device | Comparison | Any | ||
| Safety & | |||||
| Effective- | |||||
| ness Issue | |||||
| Material | - | Nitrile | Nitrile | Similar | No |
| Color | - | Black | White | ||
| Blue | |||||
| Black | |||||
| Orange | |||||
| Green | Minor | ||||
| Different | |||||
| (Supported by | |||||
| Biocompatibility Study) | No | ||||
| Product | |||||
| Code | LZA | ||||
| LZC | LZA | ||||
| LZC | Similar | No | |||
| Type of | |||||
| Use | - | Single Use | Single Use | Similar | No |
| Material | - | Nitrile | Nitrile | Similar | No |
| Powder- | |||||
| Free | - | Yes | Yes | Similar | No |
| Sterility | - | Non-sterile | Non-Sterile | Similar | No |
| Intended | |||||
| Use / | |||||
| Indications | |||||
| for Use | - | The Black Colored, | |||
| Powder Free Nitrile | |||||
| Examination Gloves, | |||||
| Non-Sterile, and Tested | |||||
| for Use with | |||||
| Chemotherapy Drugs and | |||||
| Fentanyl Citrate is a | |||||
| specialty medical glove | |||||
| which is a disposable | |||||
| device intended for | |||||
| medical purposes that is | |||||
| worn on the examiner's | |||||
| hand or finger to prevent | |||||
| contamination between | |||||
| examiner and patient. In | |||||
| addition, these gloves are | |||||
| worn to protect the | |||||
| wearer against exposure | |||||
| to chemotherapy drugs | |||||
| and Fentanyl Citrate. | Powder-Free Nitrile | ||||
| Examination Glove (White, | |||||
| Blue, Black, Orange and | |||||
| Green Color) Tested for | |||||
| Use with Chemotherapy | |||||
| Drugs and Fentanyl is a | |||||
| disposable device intended | |||||
| for medical purposes that is | |||||
| worn on the examiner's | |||||
| hand, in order to prevent | |||||
| contamination between | |||||
| patient and examiner, and | |||||
| also prevent transmission of | |||||
| a wide variety of diseases to | |||||
| both patient and health care | |||||
| personnel. In addition, | |||||
| these gloves were tested for | |||||
| chemotherapy drug | |||||
| permeation test. | Similar | No | |||
| Dimension | ASTM D6319-10 | Meets requirement | Meets requirement | Similar | No |
| Physical | |||||
| Properties | ASTM D6319-10 | Meets requirement | Meets requirement | Similar | No |
| Freedom | |||||
| from Holes | ASTM D6319-10 | ||||
| (Tested according | |||||
| to ASTM D5151- |
- | Meets requirements of
ASTM D6319-10
(ASTM D5151) | Meets ASTM D6319-10,
21 CFR 800.20 (Tested in
accordance with ASTM
D5151-06) | Similar | No |
| Powder
Residual | ASTM D6124-06 | Meets requirement | Meets requirement | Similar | No |
| Biocompati
bility | .In Vitro
Cytotoxicity-
ISO 10993-5 | Under the conditions of
the study, the device is
non-cytotoxic | Under the condition of
study, the device extract
shows potential toxicity. | Different
(Supported by
Acute
Systemic
Toxicity
Study) | No |
| | Acute Systemic
Toxicity - ISO
10993-11 | - | Not an acute systemic toxic
under the condition of the
study. | Different
(Device is
proven safe to
used) | No |
| | Skin Sensitization
- ISO 10993-10 | Under the condition of
the study, the device is
non-sensitization | Not a sensitizer under the
conditions of the study. | Similar | No |
| | Skin Irritation -
ISO 10993-10 | Under the conditions of
the study, the device is
non irritating | Not a primary skin irritant
under the conditions of the
study. | Similar | No |
6
7
| Characteristic | Predicate Device
(K200181) | Proposed Device | Comparison Analysis | Justification |
|--------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color | Black | White
Blue
Black
Orange
Green | Minor Different
(Supported by
Biocompatibility
Study) | Device in different color has
the same non-sensitization,
non-irritating and non-toxic
characteristics. |
| Biocompatibility
(In Vitro
Cytotoxicity) | Meets ISO 10993:5
Under the
conditions of the
study, the device is
non-cytotoxic | ISO 10993:5
Under the condition of
the study, the
device extract shows potential
cytotoxicity. | Different
(Supported by
Acute Systemic
Toxicity Study) | Device has potential cytotoxic
effect. Therefore, Acute
Systemic Toxicity test is
conducted to prove that
device does not have potential
toxicity. |
| Biocompatibility
(Acute Systemic
Toxicity) | - | Meets ISO 10993-11
Not an acute systemic
toxic under the
condition of the study. | Different
(Device is proven
safe to use) | Device is does not have
potential toxicity effect.
Therefore, similar with the
predicate. |
Table 6.2 Summary of Difference in Technological Characteristics
Table 6.3: Test Results for Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (ASTM D6978-05)
| Chemotherapy
| Drug | Concentration | Minimum Breakthrough Detection Time (minutes) | |||||
|---|---|---|---|---|---|---|---|
| Predicate Device | |||||||
| (K200181) | Proposed Device | ||||||
| White | Blue | Black | Orange | Green | |||
| Carmustine (BCNU)* | 3.3 mg/ml | 54.1 | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| ThioTepa* | 10.0 mg/mL | 1.3 | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100.0 mcg/2mL | >240 | >240 | >240 | >240 | >240 | >240 |
| *Warning Statement: | The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time: |
- Carmustine (3.3 mg/mL)
- Thiotepa (10 mg/mL) | | | | | |
8
7. Summary of Non-Clinical Test:
Below are the non-clinical tests that was conducted and the purposes:
| Test | Purpose |
|---|---|
| Dimension Test | To evaluate whether the device meets the current ASTM D6319-19 |
| Freedom From Hole | To evaluate whether the subject meets current 21 CFR 800.20, ASTM |
| D6319-19 and test according to ASTM D5151-19 | |
| Physical Property Test | To evaluate whether the subjects meet current ASTM D6319-19 and test |
| according to ASTM D412 and ASTM D573 | |
| Residual Powder Test | To evaluate whether the subjects meet current ASTM D6319-19 and test |
| according to ASTM D6124-06 | |
| Biocompatibility Test | |
| (Skin Irritation) | To determine whether skin irritation potential of device meets ISO 10993- |
-
|
| Biocompatibility Test
(Skin Sensitization) | To determine whether skin sensitization potential of device meets ISO
10993-10. |
| Biocompatibility Test
(Acute Systemic
Toxicity) | To determine whether leachable extracted from the device would cause
acute systemic toxicity and meet ISO 10993-11. |
Table 7.1 Summary of Dimension Test
| Standard | Minimum | Device Performance (Minimum) | ||||||
|---|---|---|---|---|---|---|---|---|
| Characteristics | Size | Requirement | White | Blue | Black | Orange | Green | |
| Length | ASTM | |||||||
| D6319- | ||||||||
| 19 | XS | 220 mm | 239 mm | 235 mm | 242 mm | 243 mm | 244 mm | |
| S | 220 mm | 236 mm | 237 mm | 242 mm | 244 mm | 241 mm | ||
| M | 230 mm | 230 mm | 230 mm | 240 mm | 245 mm | 245 mm | ||
| L | 230 mm | 234 mm | 237 mm | 255 mm | 243 mm | 242 mm | ||
| XL | 230 mm | 232 mm | 246 mm | 240 mm | 240 mm | 245 mm | ||
| XXL | 230 mm | 238 mm | 238 mm | 242 mm | 240 mm | 245 mm | ||
| Width | ASTM | |||||||
| D6319- | ||||||||
| 19 | XS | $70 \pm 10$ mm | 75 mm | 77 mm | 77 mm | 77 mm | 77 mm | |
| S | $80 \pm 10$ mm | 85 mm | 87 mm | 86 mm | 87 mm | 85 mm | ||
| M | $95 \pm 10$ mm | 93 mm | 86 mm | 92 mm | 97 mm | 97 mm | ||
| L | $110 \pm 10$ mm | 104 mm | 107 mm | 104 mm | 108 mm | 107 mm | ||
| XL | $120 \pm 10$ mm | 112 mm | 111 mm | 114 mm | 118 mm | 117 mm | ||
| XXL | $130 \pm 10$ mm | 128 mm | 128 mm | 127 mm | 124 mm | 126 mm | ||
| Thickness | ||||||||
| (Finger) | ASTM | |||||||
| D6319- | ||||||||
| 19 | XS | 0.05 mm | 0.08 mm | 0.08 mm | 0.09 mm | 0.27 mm | 0.25 mm | |
| S | 0.08 mm | 0.09 mm | 0.05 mm | 0.27 mm | 0.27 mm | |||
| M | 0.10 mm | 0.11 mm | 0.10 mm | 0.28 mm | 0.27 mm | |||
| L | 0.09 mm | 0.08 mm | 0.10 mm | 0.27 mm | 0.27 mm | |||
| XL | 0.07 mm | 0.06 mm | 0.10 mm | 0.28 mm | 0.27 mm | |||
| XXL | 0.07 mm | 0.08 mm | 0.07 mm | 0.28 mm | 0.26 mm | |||
| Thickness | ||||||||
| (Palm) | ASTM | |||||||
| D6319- | ||||||||
| 19 | XS | 0.05 mm | 0.05 mm | 0.05 mm | 0.06 mm | 0.19 mm | 0.19 mm | |
| S | 0.05 mm | 0.05 mm | 0.06 mm | 0.19 mm | 0.19 mm | |||
| M | 0.06 mm | 0.06 mm | 0.05 mm | 0.19 mm | 0.18 mm | |||
| L | 0.05 mm | 0.05 mm | 0.06 mm | 0.22 mm | 0.20 mm | |||
| XL | 0.05 mm | 0.05 mm | 0.06 mm | 0.22 mm | 0.18 mm | |||
| XXL | 0.05 mm | 0.05 mm | 0.06 mm | 0.20 mm | 0.19 mm |
9
| Characteristics | Standard | Size | Minimum
Requirement | Device Performance (Minimum) | | | | |
|-----------------------|-------------------------------------------------------------------------------------|------|------------------------|------------------------------|--------|--------|--------|--------|
| | | | | White | Blue | Black | Orange | Green |
| Freedom from
Holes | A;STM
D6319-19
21 CFR
800.20
(Tested
as per
ASTM
D5151-
19) | XS | AQL 2.5 | Passed | Passed | Passed | Passed | Passed |
| | | S | | Passed | Passed | Passed | Passed | Passed |
| | | M | | Passed | Passed | Passed | Passed | Passed |
| | | L | | Passed | Passed | Passed | Passed | Passed |
| | | XL | | Passed | Passed | Passed | Passed | Passed |
| | | XXL | | Passed | Passed | Passed | Passed | Passed |
Table 7.2 Summary of Freedom of Hole Test
Table 7.3 Summary of Physical Property Test
| Characteristics | Standard | Size | Minimum
Requirement | Device Performance (Minimum) | | | | |
|-------------------------------------|---------------------------------------|------|------------------------|------------------------------|------|-------|--------|-------|
| | | | | White | Blue | Black | Orange | Green |
| Before Aging
(Tensile [MPa]) | | XS | 14 MPa | 23.2 | 21.0 | 21.3 | 20.7 | 21.1 |
| | | S | | 21.2 | 24.5 | 23.6 | 20.0 | 20.1 |
| | | M | | 22.8 | 21.6 | 22.3 | 21.0 | 28.8 |
| | | L | | 20.7 | 23.7 | 21.6 | 21.4 | 20.9 |
| | | XL | | 20.5 | 20.2 | 24.3 | 20.9 | 22.0 |
| | | XXL | | 22.8 | 23.6 | 22.2 | 23.0 | 22.1 |
| Before Aging
(Elongation
[%]) | ASTM
D6319-
19 | XS | 500 % | 528 | 520 | 515 | 527 | 533 |
| | | S | | 527 | 549 | 518 | 515 | 556 |
| | | M | | 520 | 522 | 530 | 549 | 548 |
| | | L | | 528 | 521 | 527 | 531 | 523 |
| | | XL | | 536 | 521 | 528 | 533 | 524 |
| | | XXL | | 526 | 524 | 528 | 525 | 525 |
| After Aging
(Tensile [MPa]) | (Tested
as per
ASTM
D412-16) | XS | 14 MPa | 23.0 | 20.2 | 23.0 | 24.5 | 21.4 |
| | | S | | 20.2 | 24.6 | 26.6 | 22.7 | 20.4 |
| | | M | | 26.8 | 19.8 | 22.7 | 22.2 | 26.4 |
| | | L | | 24.9 | 26.1 | 21.4 | 25.2 | 21.7 |
| | | XL | | 26.3 | 23.1 | 28.8 | 22.2 | 24.6 |
| | | XXL | | 23.3 | 21.0 | 20.0 | 27.4 | 20.1 |
| After Aging
(Elongation
[%]) | | XS | 400 % | 432 | 461 | 414 | 430 | 465 |
| | | S | | 427 | 466 | 421 | 412 | 446 |
| | | M | | 444 | 457 | 425 | 466 | 440 |
| | | L | | 488 | 423 | 436 | 447 | 455 |
| | | XL | | 458 | 424 | 434 | 432 | 431 |
| | | XXL | | 437 | 435 | 433 | 425 | 425 |
10
| Characteristics | Standard | Size | Minimum
Requirement | Device Performance (Minimum) | | | | |
|----------------------------|--------------------------------------------------------------------|------|------------------------------------------------|------------------------------|------|-------|--------|-------|
| | | | | White | Blue | Black | Orange | Green |
| Residual
Powder
(mg) | ASTM
D6319-
19
(Tested
as per
ASTM
D6124-
06) | XS | ≤ 2.0 mg of
residual
powder per
glove | 0.98 | 0.68 | 0.80 | 0.82 | 0.96 |
| | | S | | 0.86 | 0.72 | 0.86 | 0.98 | 0.82 |
| | | M | | 0.92 | 0.88 | 0.94 | 0.92 | 0.92 |
| | | L | | 0.78 | 0.76 | 0.92 | 0.78 | 0.90 |
| | | XL | | 0.84 | 0.98 | 0.84 | 0.68 | 0.86 |
| | | XXL | | 0.74 | 0.82 | 0.92 | 0.84 | 0.98 |
Table 7.4 Summary of Residual Powder Test
Table 7.5 Summary of Biocompatibility Test
| Characteristics | Standard | Minimum
Requirement | Device Performance | | | | |
|----------------------------|--------------|------------------------|------------------------------------------------------------------|------|-------|--------|-------|
| | | | White | Blue | Black | Orange | Green |
| Skin Irritation | ISO 10993-10 | N/A | Non-irritant under the conditions of the study. | | | | |
| Skin
Sensitization | ISO 10993-10 | N/A | Non-sensitizer under the conditions of the study. | | | | |
| Acute Systemic
Toxicity | ISO 10993-11 | N/A | Not an acute systemic toxic under the condition of
the study. | | | | |
8. Summary of Clinical Test:
Clinical data is not required.
9. Conclusion:
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.