(92 days)
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. In addition, these gloves were tested respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
This device, Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is a nitrile non-sterile medical examination glove available in various sizes (from extra-small to extra-large) and packaging configuration. The gloves are non-sterile medical examination gloves, seamless, ambidextrous, five fingered. They are made from proprietary formulations composed of NBR (Nitrile Butadiene Rubber), accelerator, bulking agent, and pigment. In addition, no former release powder or chemical is used in its manufacturing process.
The provided document is a 510(k) premarket notification for a medical device: "Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with AI components. Therefore, many of the requested fields regarding AI studies, ground truth establishment, and expert involvement are not applicable or directly addressed in this submission.
However, I can extract the acceptance criteria and the device's performance based on the non-clinical bench testing for the physical and chemical resistance properties of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions | ||
| Length (XS&S) | ≥ 220 mm | Pass |
| Length (M&L&XL) | ≥ 230 mm | Pass |
| Thickness (Palm) | ≥ 0.05 mm min. | Pass |
| Thickness (Finger) | ≥ 0.05 mm min. | Pass |
| Palm Width (X-small) | 70 ± 10 mm | Pass |
| Palm Width (Small) | 85 ± 10 mm | Pass |
| Palm Width (Medium) | 95 ± 10 mm | Pass |
| Palm Width (Large) | 110 ± 10 mm | Pass |
| Palm Width (X-Large) | 120 ± 10 mm | Pass |
| Freedom from holes (Water leak) | G-I/AQL 2.5 | Pass |
| Tensile strength (Before aging) | 14 MPa, min. | Pass |
| Tensile strength (After aging) | 14 MPa, min. | Pass |
| Elongation (Before aging) | 500% min. | Pass |
| Elongation (After aging) | 400% min. | Pass |
| Powder Residual | < 2mg per glove | Pass |
| Biocompatibility - Cytotoxicity | No in vitro cytotoxic as described in ISO 10993-5 | Pass |
| Biocompatibility - Skin Sensitization | No dermal reactions indicative of delayed contact hypersensitivity | Pass |
| Biocompatibility - Skin Irritation | Not dermal irritation reactions | Pass |
| Resistance of Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate | The resistance of the device to permeation were challenged against 37 chemotherapy drugs and Fentanyl Citrate to determine Minimum Breakthrough Detection Time (Min.). The specific times for each drug are listed in the "Minimum Breakthrough Detection Time (Min.)" column below. | Pass (for all tested drugs, with specific breakthrough times as indicated below) |
| Specific Breakthrough Times for Chemotherapy Drugs and Fentanyl Citrate | ||
| 1. Bleomycin Sulfate 15.0 mg/ml | > 240 min. | > 240 |
| 2. Busulfan 6.0 mg/ml | > 240 min. | > 240 |
| 3. Carboplatin 10.0 mg/ml | > 240 min. | > 240 |
| 4. Carmustine (BCNU) 3.3 mg/ml | 59.4 min. | 59.4 |
| 5. Chloroquine 50.0 mg/ml | > 240 min. | > 240 |
| 6. Cisplatin 1 mg/ml | > 240 min. | > 240 |
| 7. Cyclophosphamide 20 mg/ml | > 240 min. | > 240 |
| 8. Cyclosporin A 100.0 mg/ml | > 240 min. | > 240 |
| 9. Cytarabine 100.0 mg/ml | > 240 min. | > 240 |
| 10. Dacarbazine (DTIC), 10.0 mg/ml | > 240 min. | > 240 |
| 11. Daunorubicin 5.0 mg/ml | > 240 min. | > 240 |
| 12. Docetaxel 10.0 mg/ml | > 240 min. | > 240 |
| 13. Doxorubicin Hydrochloride 2.0 mg/ml | > 240 min. | > 240 |
| 14. Epirubicin 2.0 mg/ml | > 240 min. | > 240 |
| 15. Etoposide (Toposar) 20.0 mg/ml | > 240 min. | > 240 |
| 16. Fludarabine 25.0 mg/ml | > 240 min. | > 240 |
| 17. Fluorouracil 50.0 mg/ml | > 240 min. | > 240 |
| 18. Gemcitabine 38.0 mg/ml | > 240 min. | > 240 |
| 19. Idarubicin 1.0 mg/ml | > 240 min. | > 240 |
| 20. Ifosfamide 50.0 mg/ml | > 240 min. | > 240 |
| 21. Irinotecan 20.0 mg/ml | > 240 min. | > 240 |
| 22. Mechlorethamine HCl 1.0 mg/ml | > 240 min. | > 240 |
| 23. Melphalan 5.0 mg/ml | > 240 min. | > 240 |
| 24. Methotrexate 25 mg/ml | > 240 min. | > 240 |
| 25. Mitomycin C 0.5 mg/ml | > 240 min. | > 240 |
| 26. Mitoxantrone 2.0 mg/ml | > 240 min. | > 240 |
| 27. Oxaliplatin 2.0 mg/ml | > 240 min. | > 240 |
| 28. Paclitaxel (Taxol), 6.0 mg/ml | > 240 min. | > 240 |
| 29. Paraplatin 10 mg/ml | > 240 min. | > 240 |
| 30. Retrovir 10 mg/ml | > 240 min. | > 240 |
| 31. Rituximab 10 mg/ml | > 240 min. | > 240 |
| 32. Thiotepa, 10.0 mg/ml | 118.5 min. | 118.5 |
| 33. Topotecan HCl 1.0 mg/ml | > 240 min. | > 240 |
| 34. Trisonex 1.0 mg/ml | > 240 min. | > 240 |
| 35. Velcade (Bortezomib) 1.0 mg/ml | > 240 min. | > 240 |
| 36. Vincristine 1.0 mg/ml | > 240 min. | > 240 |
| 37. Fentanyl Citrate Injection 100 mcg/2ml | > 240 min. | > 240 |
Study Proving Device Meets Acceptance Criteria:
The device's performance against the acceptance criteria was demonstrated through non-clinical bench testing. The tests were conducted according to recognized international and ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size (number of gloves or test replicates) used for each individual bench test. The data provenance is derived from the testing of the "Disposable Powder Free Nitrile Examination Glove, Natural Blue Color." Since this is a submission by Ever Growth (Vietnam) Corporation Limited, it is highly probable the testing was conducted in Vietnam or a related testing facility, and the data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable to this type of device and study. The "ground truth" for the performance criteria (e.g., tensile strength, breakthrough time) is established by the specifications defined in the referenced ASTM and ISO standards, not by human expert consensus or interpretation of complex data. The tests are objective measurements.
4. Adjudication Method for the Test Set:
This is not applicable. The tests performed are objective, quantitative measurements against predefined numerical and qualitative criteria (e.g., pass/fail for cytotoxicity, specific values for length/thickness, minimum breakthrough times). There is no need for expert adjudication in the context of these physical and chemical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This device is a nitrile examination glove, a physical medical product, and does not involve AI or software components that would require an MRMC study or assessment of human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is a physical medical glove and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by objective measurements against established engineering and safety standards.
- For physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residual), the ground truth is defined by the requirements of standards like ASTM D3767, D5151-19, D412-16, D573-04, D6124-06, and 21 CFR 800.20.
- For biocompatibility (cytotoxicity, skin sensitization, skin irritation), the ground truth is defined by the criteria within ISO 10993-5:2009, ISO 10993-10:2021, and CPSC standards.
- For chemical permeation, the ground truth is the "Minimum Breakthrough Detection Time" measured according to ASTM D6978-05.
8. The Sample Size for the Training Set:
This is not applicable. This device is a physical medical product, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This is not applicable. As there is no training set for an AI/ML algorithm, this question does not apply.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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.
March 27, 2024
Ever Growth (Vietnam) Corporation Limited Deng Elizabeth U.S. Agent Long Khanh Industrial Zone, Binh Loc Commune. Long Khanh City, Dong Nai 76461 Vietnam
Re: K234097
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, 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: December 1, 2023 Received: December 26, 2023
Dear Deng Elizabeth:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}------------------------------------------------
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K234097
Device Name
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
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. In addition, these gloves were tested respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| No. | Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) |
|---|---|---|
| 1 | Bleomycin Sulfate 15.0 mg/ml | > 240 |
| 2 | Busulfan 6.0 mg/ml | > 240 |
| 3 | Carboplatin 10.0 mg/ml | > 240 |
| 4 | Carmustine (BCNU) 3.3 mg/ml | 59.4 |
| 5 | Chloroquine 50.0 mg/ml | > 240 |
| 6 | Cisplatin 1 mg/ml | > 240 |
| 7 | Cyclophosphamide 20 mg/ml | > 240 |
| 8 | Cyclosporin A 100.0 mg/ml | > 240 |
| 9 | Cytarabine 100.0 mg/ml | > 240 |
| 10 | Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| 11 | Daunorubicin 5.0 mg/ml | > 240 |
| 12 | Docetaxel 10.0 mg/ml | > 240 |
| 13 | Doxorubicin Hydrochloride 2.0 mg/ml | > 240 |
| 14 | Epirubicin 2.0 mg/ml | > 240 |
| 15 | Etoposide (Toposar) 20.0 mg/ml | > 240 |
| 16 | Fludarabine 25.0 mg/ml | > 240 |
| 17 | Fluorouracil 50.0 mg/ml | > 240 |
| 18 | Gemcitabine 38.0 mg/ml | > 240 |
| 19 | Idaribicin 1.0 mg/ml | > 240 |
| 20 | Ifosfamide 50.0 mg/ml | > 240 |
| 21 | Irinotecan 20.0 mg/ml | > 240 |
| 22 | Mechlorethamine HCl 1.0 mg/ml | > 240 |
| 23 | Melphalan 5.0 mg/ml | > 240 |
| 24 | Methotrexate 25 mg/ml | > 240 |
| 25 | Mitomycin C 0.5 mg/ml | > 240 |
| 26 | Mitoxantrone 2.0 mg/ml | > 240 |
| 27 | Oxaliplatin 2.0 mg/ml | > 240 |
| 28 | Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| 29 | Paraplatin 10 mg/ml | > 240 |
| 30 | Retrovir 10 mg/ml | > 240 |
| 31 | Rituximab 10 mg/ml | > 240 |
| 32 | Thiotepa, 10.0 mg/ml | 118.5 |
| 33 | Topotecan HCl 1.0 mg/ml | > 240 |
| 34 | Trisonex 1.0 mg/ml | > 240 |
| 35 | Velcade (Bortezomib) 1.0 mg/ml | > 240 |
| 36 | Vincristine 1.0 mg/ml | > 240 |
{4}------------------------------------------------
Fentanyl Citrate Injection 100 mcg/2ml
Thiotepa and Carmustine have low permeation times
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)
240
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{5}------------------------------------------------
0.0 Summary Preparation Date: March 23, 2024
1.0 Submitter:
Submitter's name:
Submitter's address:
Phone number: Fax number: Name of contact person:
2.0 US Agent:
US Representative Name: Company Address:
Telephone Number: Contact Email Address:
3.0 Name of the Device
Proprietary/Trade name:
Common Name:
Classification Name: Device Classification: Regulation Number: Product Code:
4.0 Predicate device
Device Name:
Company name:
510(K) Number:
EVER GROWTH (VIETNAM) CORPORATION LIMITED Long Khanh Industrial Zone, Binh Loc Commune, Long Khanh City, Dong Nai, VN 76461 84-61-3514022 84-61-3514023 Jerry Lin
Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California Rancho Cucamonga, CA 91739 909 4659188 baxianunited48(@yahoo.com
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Non-powdered Patient Examination Glove Class I 21 CFR 880.6250 LZA, LZC, OPJ, QDO
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested for Use with Chemotherapy Drugs EVER GROWTH (VIETNAM) CORPORATION LIMITED K190736
{6}------------------------------------------------
5.0 Device Description:
This device, Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is a nitrile non-sterile medical examination glove available in various sizes (from extra-small to extra-large) and packaging configuration. The gloves are non-sterile medical examination gloves, seamless, ambidextrous, five fingered. They are made from proprietary formulations composed of NBR (Nitrile Butadiene Rubber), accelerator, bulking agent, and pigment. In addition, no former release powder or chemical is used in its manufacturing process.
6.0 Device Indications for use:
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. In addition, these gloves were tested respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by
| No. | Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.)* |
|---|---|---|
| 1 | Bleomycin Sulfate 15.0 mg/ml | > 240 |
| 2 | Busulfan 6.0 mg/ml | > 240 |
| 3 | Carboplatin 10.0 mg/ml | > 240 |
| 4 | Carmustine (BCNU) 3.3 mg/ml | 59.4 |
| 5 | Chloroquine 50.0 mg/ml | > 240 |
| 6 | Cisplatin 1 mg/ml | > 240 |
| 7 | Cyclophosphamide 20 mg/ml | > 240 |
| 8 | Cyclosporin A 100.0 mg/ml | > 240 |
| 9 | Cytarabine 100.0 mg/ml | > 240 |
| 10 | Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| 11 | Daunorubicin 5.0 mg/ml | > 240 |
| 12 | Docetaxel 10.0 mg/ml | > 240 |
| 13 | Doxorubicin Hydrochloride 2.0 mg/ml | > 240 |
| 14 | Epirubicin 2.0 mg/ml | > 240 |
| 15 | Etoposide (Toposar), 20.0 mg/ml | > 240 |
| 16 | Fludarabine 25.0 mg/ml | > 240 |
| 17 | Fluorouracil 50.0 mg/ml | > 240 |
| 18 | Gemcitabine 38.0 mg/ml | > 240 |
{7}------------------------------------------------
| No. | Test Chemotherapy Drug and Concentration | Minimum BreakthroughDetection Time (Min.)* |
|---|---|---|
| 19 | Idaribicin 1.0 mg/ml | > 240 |
| 20 | Ifosfamide 50.0 mg/ml | > 240 |
| 21 | Irinotecan 20.0 mg/ml | > 240 |
| 22 | Mechlorethamine HCl 1.0 mg/ml | > 240 |
| 23 | Melphalan 5.0 mg/ml | > 240 |
| 24 | Methotrexate 25 mg/ml | > 240 |
| 25 | Mitomycin C 0.5 mg/ml | > 240 |
| 26 | Mitoxantrone 2.0 mg/ml | > 240 |
| 27 | Oxaliplatin 2.0 mg/ml | > 240 |
| 28 | Paclitaxel (Taxol) 6.0 mg/ml | > 240 |
| 29 | Paraplatin 10 mg/ml | > 240 |
| 30 | Retrovir 10 mg/ml | > 240 |
| 31 | Rituximab 10 mg/ml | > 240 |
| 32 | Thiotepa 10.0 mg/ml | 118.5 |
| 33 | Topotecan HCl 1.0 mg/ml | > 240 |
| 34 | Trisonex 1.0 mg/ml | > 240 |
| 35 | Velcade (Bortezomib) 1.0 mg/ml | > 240 |
| 36 | Vincristine 1.0 mg/ml | > 240 |
| Fentanyl Citrate Test | ||
| Fentanyl Citrate Injection100 mcg/2ml | >240 |
*The maximum testing time is 240 minutes
Please note that the following drug has an extremely low permeation time:
| No. | Test Chemotherapy Drug and Concentration | Minimum BreakthroughDetection Time (Min.) |
|---|---|---|
| 4 | Carmustine (BCNU) 3.3 mg/ml | 59.4 |
| 32 | Thiotepa, 10.0 mg/ml | 118.5 |
{8}------------------------------------------------
7.0 Comparison of device technological characteristics:
| DeviceCharacteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Product Name | Disposable Powder Free NitrileExamination Glove, Blue Color,Tested for Use withChemotherapy Drugs | Disposable Powder Free NitrileExamination Glove, NaturalBlue Color, Tested for Use withChemotherapy Drugs andFentanyl Citrate | same exceptcolor |
| 510(K) No. | K190736 | K234097 | n/a |
| Product Owner | Ever Growth (Vietnam)Corporation Limited | Ever Growth (Vietnam)Corporation Limited | same |
| Product Code | LZA & LZC | LZA & LZC, OPJ, QDO | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Indications forUse | A patient examination gloves is adisposable device intended formedical purpose that is worn onthe examiner's hand or fingers toprevent contamination betweenpatient and examiner. Inaddition, these gloves weretested for use with chemotherapydrugs in accordance with ASTMD6978-05 Standard Practice forAssessment of Medical gloves toPermeation by ChemotherapyDrugs. | A patient examination gloves is adisposable device intended formedical purpose that is worn onthe examiner's hand or fingers toprevent contamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs andFentanyl citrate in accordancewith ASTM D6978-05 StandardPractice for Assessment ofMedical gloves to Permeationby Chemotherapy Drugs. | similar |
| Power free | Yes | Yes | same |
| Size | XS/S/M/L/XL | XS/S/M/L/XL | same |
| Over-The-Counter Use | Yes (21 CFR 801 Subpart C) | Yes (21 CFR 801 Subpart C) | same |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | same |
| Dimensions-Length | Complies with ASTM D6319-10≥ 230 mm | Complies with ASTM D6319-19XS&S ≥ 220 mm;M&L&XL ≥ 230 mm | similar |
| Dimensions -Palm Width | Complies with ASTM D6319-10XS: 70 ± 10 mm;S: 80 ± 10 mm;M: 95 ± 10 mm;L: 110 ± 10 mm;XL: 120 ± 10 mm | Complies with ASTM D6319-19XS: 70 ± 10 mm;S: 80 ± 10 mm;M: 95 ± 10 mm;L: 110 ± 10 mm;XL: 120 ± 10 mm | same |
| Dimensions -Thickness | Complies with ASTM D6319-10Palm ≥0.05 mm;Finger ≥0.05 mm | Complies with ASTM D6319-19Palm ≥0.05 mm;Finger ≥0.05 mm | same |
{9}------------------------------------------------
| DeviceCharacteristic | Predicate Device | Subject Device | Comparison | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PhysicalProperties | Complies with ASTM D6319-10Tensile StrengthBefore aging≥14MPaAfter aging ≥14MPa | Complies with ASTM D6319-19Tensile StrengthBefore aging≥14MPaAfter aging ≥14MPa | same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Complies with ASTM D6319-10Elongation:Before Aging: 500% min.After Aging: 400% min. | Complies with ASTM D6319-19Elongation:Before Aging: 500% min.After Aging: 400% min. | same | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Residualpowder | Complies with ASTM D6319-10< 2mg per glove | Complies with ASTM D6319-19< 2mg per glove | same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Freedom fromHoles | In accordance with ASTM DD6319-10 (G-1 with AQL 2.5) | In accordance with ASTMD6319-19 (G-1 with AQL 2.5) | same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Biocompatibility | AAMI/ ANSI/ ISO 10993-5, Invitro cytotoxicity test: Passes | ISO 10993-5: 2009, In vitrocytotoxicity test: Pass | same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| AAMI/ANSI/ISO 10993-10,Skin sensitization test & SkinIrritation test: Passes | 10993-10:2021, Tests for skinsensitization: PassCPSC standards regulated underthe FHSA Act set forth in 16CFR 1500.41,Irritation/Corrosion Test: Pass | similar | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Resistance ofGloves toPermeation byChemotherapyDrugs | no. Test ChemotherapyDrug andConcentration MinimumBreakthroughDetectionTime(Min.) 1 Bleomycin Sulfate15.0 mg/ml > 240 2 Busulfan 6.0 mg/ml > 240 3 Carboplatin 10.0mg/ml > 240 4 Carmustine (BCNU),3.3 mg/ml 59.4 5 Chloroquine 50.0mg/ml > 240 6 Cisplatin 1.0 mg/ml > 240 7 Cyclophosphamide20 mg/ml > 240 8 Cyclosporin A 100.0mg/ml > 240 9 Cytarabine 100.0mg/ml > 240 10 Dacarbazine (DTIC),10.0 mg/ml > 240 11 Daunorubicin 5.0mg/ml > 240 12 Docetaxel 10.0mg/ml > 240 | no. Test ChemotherapyDrug andConcentration MinimumBreakthroughDetectionTime(Min.) 1 Bleomycin Sulfate15.0 mg/ml > 240 2 Busulfan 6.0 mg/ml > 240 3 Carboplatin 10.0mg/ml > 240 4 Carmustine (BCNU),3.3 mg/ml 59.4 5 Chloroquine 50.0mg/ml > 240 6 Cisplatin 1.0 mg/ml > 240 7 Cyclophosphamide20 mg/ml > 240 8 Cyclosporin A 100.0mg/ml > 240 9 Cytarabine 100.0mg/ml > 240 10 Dacarbazine (DTIC),10.0 mg/ml > 240 11 Daunorubicin 5.0mg/ml > 240 12 Docetaxel 10.0mg/ml > 240 | similar |
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| 13 | DoxorubicinHydrochloride, 2.0mg/ml | > 240 | 13 | DoxorubicinHydrochloride, 2.0mg/ml | > 240 | |
|---|---|---|---|---|---|---|
| 14 | Epirubicin 2.0 mg/ml | > 240 | 14 | Epirubicin 2.0 mg/ml | > 240 | |
| 15 | Etoposide (Toposar),20.0 mg/ml | > 240 | 15 | Etoposide (Toposar),20.0 mg/ml | > 240 | |
| 16 | Fludarabine 25.0mg/ml | > 240 | 16 | Fludarabine 25.0mg/ml | > 240 | |
| 17 | Fluorouracil, 50.0mg/ml | > 240 | 17 | Fluorouracil, 50.0mg/ml | > 240 | |
| 18 | Gemcitabine 38.0mg/ml | > 240 | 18 | Gemcitabine 38.0mg/ml | > 240 | |
| 19 | Idaribicin 1.0 mg/ml | > 240 | 19 | Idaribicin 1.0 mg/ml | > 240 | |
| 20 | Ifosfamide 50.0mg/ml | > 240 | 20 | Ifosfamide 50.0mg/ml | > 240 | |
| 21 | Irinotecan 20.0mg/ml | > 240 | 21 | Irinotecan 20.0mg/ml | > 240 | |
| 22 | MechlorethamineHCl 1.0 mg/ml | > 240 | 22 | MechlorethamineHCl 1.0 mg/ml | > 240 | |
| 23 | Melphalan 5.0 mg/ml | > 240 | 23 | Melphalan 5.0 mg/ml | > 240 | |
| 24 | Methotrexate 25mg/ml | > 240 | 24 | Methotrexate 25mg/ml | > 240 | |
| 25 | Mitomycin C 0.5mg/ml | > 240 | 25 | Mitomycin C 0.5mg/ml | > 240 | |
| 26 | Mitoxantrone 2.0mg/ml | > 240 | 26 | Mitoxantrone 2.0mg/ml | > 240 | |
| 27 | Oxaliplatin 2.0 mg/ml | > 240 | 27 | Oxaliplatin 2.0 mg/ml | > 240 | |
| 28 | Paclitaxel (Taxol),6.0 mg/ml | > 240 | 28 | Paclitaxel (Taxol),6.0 mg/ml | > 240 | |
| 29 | Paraplatin 10 mg/ml | > 240 | 29 | Paraplatin 10 mg/ml | > 240 | |
| 30 | Retrovir 10 mg/ml | > 240 | 30 | Retrovir 10 mg/ml | > 240 | |
| 31 | Rituximab 10 mg/ml | > 240 | 31 | Rituximab 10 mg/ml | > 240 | |
| 32 | Thiotepa, 10.0 mg/ml | 118.5 | 32 | Thiotepa, 10.0 mg/ml | 118.5 | |
| 33 | Topotecan HCl 1.0mg/ml | > 240 | 33 | Topotecan HCl 1.0mg/ml | > 240 | |
| 34 | Trisonex 1.0 mg/ml | > 240 | 34 | Trisonex 1.0 mg/ml | > 240 | |
| 35 | Velcade(Bortezomib) 1.0mg/ml | > 240 | 35 | Velcade(Bortezomib) 1.0mg/ml | > 240 | |
| 36 | Vincristine 1.0 mg/ml | > 240 | 36 | Vincristine 1.0 mg/ml | > 240 | |
| 37 | Fentanyl CitrateInjection100 mcg/2ml | n/a | 37 | Fentanyl CitrateInjection100 mcg/2ml | >240 |
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8.0 Assessment of Non-Clinical Performance Data:
The following bench testing was conducted for the Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.:
| Test | Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D3767 | Determine thegeometricaldimension of gloves | Length: XS&S ≥ 220 mm; M&L&XL ≥230 mm.Thickness:Palm - 0.05 mm min.Finger - 0.05 mm min.Palm Width:X-small 70 ± 10 mmSmall 85 ± 10 mmMedium 95 ± 10 mmLarge 110 ± 10 mmX-Large 120 ± 10 mm | Pass |
| Freedom fromholes (Water leak) | 21 CFR 800.20.&ASTM D5151-19 | Detect the holes onthe gloves. | G-I/AQL 2.5 | Pass |
| Tensile strength(Beforeaging/After aging) | ASTM D412-16& ASTM D573-04 | Evaluate the tensile(tenson) properties ofthe gloves. Inaddition, it alsodetermines the | Before Aging: 14 MPa,min.After Aging: 14 MPa,min | Pass |
| Elongation (Beforeaging/After aging) | ASTM D412-16& ASTM D573-04 | influence of elevatedtemperature on thephysical properties ofgloves. | Before Aging: 500%min.After Aging: 400% min. | Pass |
| Powder Residual | ASTM D6124-06 | Determine theaverage powder massfound on the gloves | < 2mg per glove | Pass |
| Biocompatibility-cytotoxicity | ISO 10993-5:2009 | determine thecytotoxicity potentialof glove | No in vitro cytotoxic asdescribed inISO 10993-5 | Pass |
| Biocompatibility-Skin Sensitization | ISO 10993-10:2021 | determine thepotential of glove topromote skinsensitization afterrepeated applications | No dermal reactionsindicative ofdelayed contacthypersensitivity | Pass |
| Biocompatibility-Skin Irritation | CPSC standardsregulated underthe FHSA Act setforth in 16 CFR1500.41 | determine thepotential of glove topromote irritationreactions afterrepeated applications | Not dermal irritationreactions | Pass |
| Test | Test Method | Purpose | Acceptance Criteria | Results |
| Resistance ofGloves toPermeation byChemotherapyDrugs | ASTM D6978-05 | Assessment ofmedical gloves topermeation bychemotherapy drugs. | The resistance of ourdevice to permeationwere challenged against37 chemotherapy drugsand Fentanyl Citrate | Pass |
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9.0 Assessment of Clinical Performance Data:
Clinical data is not needed for this type of device.
10.0 Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.