(38 days)
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, fentanyl citrate, and xylazine in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
The provided document is a 510(k) Premarket Notification for a Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine.
This device is a Class I medical device (non-powered patient examination glove). For devices in this class, the FDA typically does not require a clinical performance study with human subjects. Instead, evidence of substantial equivalence to a predicate device is primarily demonstrated through non-clinical performance data (bench testing).
Therefore, the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to this particular device submission. This document describes the performance of a physical examination glove, not an AI or imaging device.
However, I can extract the acceptance criteria and reported device performance from the non-clinical testing:
Acceptance Criteria and Reported Device Performance
The study aims to demonstrate that the subject device (Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine) meets the acceptance criteria for various physical and chemical resistance properties, establishing its substantial equivalence to a predicate device (K193555).
Here is a table summarizing the acceptance criteria and the device's reported performance:
| Test | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM D6319-19 | Length:Short cuff: ≥230mmLong cuff: ≥300mmThickness:Palm: ≥ 0.05 mmFinger: ≥ 0.05 mmCuff: ≥ 0.05 mmPalm Width:XS: 70 ± 10 mm;S: 80 ± 10 mm;M: 95 ± 10 mm;L: 110 ± 10 mm;XL: 120 ± 10 mm | Pass |
| Freedom from holes (Water leak) | 21 CFR 800.20 & ASTM D5151-19 | G-I/ AQL 2.5 | Pass |
| Tensile strength (Before aging/ After aging) | ASTM D6319-19 | Before Aging: ≥14MPaAfter Aging: ≥14MPa | Pass |
| Elongation (Before aging/ After aging) | ASTM D6319-19 | Before Aging: ≥500%After Aging: ≥400% | Pass |
| Powder Residual | ASTM D6319-19 | < 2mg per glove | Pass |
| Biocompatibility - Cytotoxicity | AAMI/ANSI/ISO 10993-5 | No in vitro cytotoxic as described in ISO 10993-5 | Pass |
| Biocompatibility - Skin Sensitization and Irritation | AAMI/ANSI/ISO 10993-10 | No dermal reactions indicative of delayed contact hypersensitivityNo skin irritation, cumulative irritation index to be 0. | Pass |
| Resistance of Gloves to Permeation by Chemotherapy Drugs | ASTM D6978-05 | The resistance of the device to permeation were challenged against 57 liquid hazardous drugs. The target for most drugs (55 out of 57) was >240 minutes minimum breakthrough detection time. For Carmustine (BCNU) and Thiotepa, specific lower breakthrough times were accepted (21.5 minutes and 13.6 minutes, respectively), with warnings provided. For Xylazine, no breakthrough was detected for up to 240 minutes. | Pass (as detailed in the tables for each drug) |
Regarding the specific questions about AI/imaging studies:
- 2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical tests on glove samples.
- 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for physical properties is established by standardized testing methods.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Results are quantitative measurements from lab tests.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not an AI or imaging device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through adherence to recognized international/national standards for medical glove testing (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6978-05, AAMI/ANSI/ISO 10993-5, AAMI/ANSI/ISO 10993-10). These standards define the test methods and performance requirements.
- 8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable. Manufacturing controls and quality assurance ensure consistency, not a "training set" in the context of AI.
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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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 6, 2025
Ever Global (Vietnam) Enterprise Corporation Elizabeth Deng U.S. Agent Long Thanh Industrial Zone Taman Village, Dong Nai Province 810000 Vietnam
Re: K244034
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: December 27, 2024 Received: December 30, 2024
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 (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.
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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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows the text "ALLAN GUAN -S" in a large, bold, sans-serif font. The text is black and the background is white. The letters are evenly spaced and the text is centered.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K244034
Device Name
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
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, fentanyl citrate, and xylazine in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
| Tested Chemotherapy and | Concentration(mg/ml) | Minimum Breakthrough Detection Time(Min) |
|---|---|---|
| Other Liquid Hazardous Drug | ||
| 01 Arsenic Trioxide | 1.0 | > 240 |
| 02 Azacitidine (Vidaza) | 25.0 | > 240 |
| 03 Bendamustine HCl | 5.0 | > 240 |
| 04 Bleomycin Sulfate | 15.0 | > 240 |
| 05 Bortezomib (Velcade) | 1.0 | > 240 |
| 06 Busulfan | 6.0 | > 240 |
| 07 Carboplatin | 10.0 | > 240 |
| 08 Carfilzomib | 2.0 | > 240 |
| 09 Carmustine (BCNU) | 3.3 | 21.5 |
| 10 Cetuximab (Erbitux) | 2.0 | > 240 |
| 11 Chloroquine | 50.0 | > 240 |
| 12 Cisplatin | 1.0 | > 240 |
| 13 Cladribine | 1.0 | > 240 |
| 14 Cyclophosphamide | 20.0 | > 240 |
| 15 Cyclosporine A | 100.0 | > 240 |
| 16 Cytarabine | 100.0 | > 240 |
| 17 Cytovene (Ganciclovir) | 10.0 | > 240 |
| 18 Dacarbazine | 10.0 | > 240 |
| 19 Daunorubicin | 5.0 | > 240 |
| 20 Decitabine | 5.0 | > 240 |
| 21 Docetaxel | 10.0 | > 240 |
| 22 Doxorubicin Hydrochloride | 2.0 | > 240 |
| 23 Epirubicin (Ellence) | 2.0 | > 240 |
| 24 Etoposide | 20.0 | > 240 |
| 25 Fludarabine | 25.0 | > 240 |
| 26 Fluorouracil | 50.0 | > 240 |
| 27 Fulvestrant | 50.0 | > 240 |
| 28 Gemcitabine | 38.0 | > 240 |
| 29 Idarubicin | 1.0 | > 240 |
| 30 Ifosfamide | 50.0 | > 240 |
| 31 Irinotecan | 20.0 | > 240 |
| 32 Mechlorethamine HCl | 1.0 | > 240 |
| 33 Melphalan | 5.0 | > 240 |
| 34 Methotrexate | 25.0 | > 240 |
| 35 Mesna | 100.0 | > 240 |
| 36 Mitomycin C | 0.5 | > 240 |
| 37 Mitoxantrone | 2.0 | > 240 |
| 38 Oxaliplatin | 5.0 | > 240 |
| 39 Paclitaxel | 6.0 | > 240 |
| 40 Paraplatin | 10.0 | > 240 |
| 41 Pemetrexed | 25.0 | > 240 |
| 42 Pertuzumab | 30.0 | > 240 |
| 43 Raltitrexed | 0.5 | > 240 |
| 44 Retrovir | 10.0 | > 240 |
| 45 Rituximab | 10.0 | > 240 |
| 46 Temsirolimus | 25.0 | > 240 |
| 47 Thiotepa | 10.0 | 13.6 |
| 48 Topotecan HCl | 1.0 | > 240 |
| 49 Trastuzumab | 21.0 | > 240 |
| 50 Triclosan | 2.0 | > 240 |
| 51 Trisenox | 1.0 | > 240 |
| 52 Vinblastine | 1.0 | > 240 |
| 53 Vincristine Sulfate | 1.0 | > 240 |
| 54 Vinorelbine | 10.0 | > 240 |
| 55 Zoledronic Acid | 0.8 | > 240 |
| 56 Fentanyl Citrate | 100.0 mcg/ 2.0 ml | > 240 |
FORM FDA 3881 (8/23)
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Warning: do not use with Carmustine and Thiotepa.
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 | 21.5 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml | 13.6 minutes |
Xylazine Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Xylazine HCl Injection (100.0 mg/ml) was found to have no breakthrough detected for up to 240 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)
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Image /page/5/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'EG' in a stylized font, with the 'E' in yellow and the 'G' in yellow. The letters are set against a blue background that resembles a hand. The words 'EVER GLOBAL' are at the top of the logo, and the words 'ENTERPRISE CORP' are at the bottom.
USTRIAL ZONE, TAMAN VILLAGE, DONG (0251)351 4023
510(k) SUMMARY
Elizabeth Deng
909 4659188
Xylazine
Class I
21 CFR 880.6250
LZA, LZC, QDO, OPJ
5748 Eaglewood Place
Rancho Cucamonga, California Rancho Cucamonga, CA 91739
baxianunited48(@yahoo.com
And Fentanyl Citrate And Xylazine
0.0 Summary Preparation Date: February 5, 2025
1.0 Submitter:
Submitter's name: Submitter's address:
Phone number: Fax number: Name of contact person:
Ever Global (Vietnam) Enterprise Corporation Long Thanh Industrial Zone, Taman Village, Dong Nai Province, Long Thanh District, VN 810000 84-61-3514022 84-61-3514023 Jerry Lin
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs
Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs And Fentanyl Citrate And
Non-powdered Patient Examination Glove
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: 510(K) Number:
4.0 Predicate device
Device Name:
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate Ever Global (Vietnam) Enterprise Corporation K193555
Company name: 510(K) Number:
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features a blue square with a stylized yellow handprint in the background. The letters "E" and "G" are overlaid in yellow on top of the handprint. The words "EVER GLOBAL" are at the top of the square, and "ENTERPRISE CORP." are at the bottom.
ONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG AX: (0251)351 4023 02-
SUPERIEURVIETNAM
510(k) SUMMARY
5.0 Device Description:
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
6.0 Device 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, fentanyl citrate, and xylazine in accordance with ASTM D6978-05 standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
| No. | Tested Chemotherapy and Other LiquidHazardous Drug and Concentration | Minimum BreakthroughDetection Time (Min.) |
|---|---|---|
| 1 | Arsenic Trioxide (1.0 mg/ml) | >240 |
| 2 | Azacitidine (Vidaza) (25.0 mg/ml) | >240 |
| 3 | Bendamustine HCl (5.0 mg/ml) | >240 |
| 4 | Bleomycin Sulfate (15.0 mg/ml) | >240 |
| 5 | Bortezomib (Velcade) (1.0 mg/ml) | >240 |
| 6 | Busulfan (6.0 mg/ml) | >240 |
| 7 | Carboplatin (10.0 mg/ml) | >240 |
| 8 | Carfilzomib (2.0 mg/ml) | >240 |
| 9 | Carmustine (BCNU), (3.3 mg/ml) | 21.5 |
| 10 | Cetuximab (Erbitux) (2.0 mg/ml) | >240 |
| 11 | Chloroquine (50.0 mg/ml) | >240 |
| 12 | Cisplatin (1.0 mg/ml) | >240 |
| 13 | Cladribine (1.0 mg/ml) | >240 |
| 14 | Cyclophosphamide (20.0 mg/ml) | >240 |
| 15 | Cyclosporin A (100.0 mg/ml) | >240 |
| 16 | Cytarabine (100.0 mg/ml) | >240 |
| 17 | Cytovene (Ganciclovir) (10.0 mg/ml) | >240 |
| 18 | Dacarbazine (DTIC), (10.0 mg/ml) | >240 |
| 19 | Daunorubicin (5.0 mg/ml) | >240 |
| 20 | Decitabine (5.0 mg/ml) | >240 |
| 21 | Docetaxel (10.0 mg/ml) | >240 |
| 22 | Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| 23 | Epirubicin (Ellence) (2.0 mg/ml) | >240 |
| 24 | Etoposide, (20.0 mg/ml) | >240 |
| 25 | Fludarabine (25.0 mg/ml) | >240 |
| 26 | Fluorouracil, (50.0 mg/ml) | >240 |
| 27 | Fulvestrant (50.0 mg/ml) | >240 |
| 28 | Gemcitabine (38.0 mg/ml) | >240 |
| 29 | Idaribicin (1.0 mg/ml) | >240 |
| 30 | Ifosfamide (50.0 mg/ml) | >240 |
| 31 | Irinotecan (20.0 mg/ml) | >240 |
| 32 | Mechlorethamine HCl (1.0 mg/ml) | >240 |
| 33 | Melphalan (5.0 mg/ml) | >240 |
| 34 | Methotrexate (25 mg/ml) | >240 |
| 35 | Mesna (100 mg/ml) | >240 |
| 36 | Mitomycin C (0.5 mg/ml) | >240 |
| 37 | Mitoxantrone (2.0 mg/ml) | >240 |
| 38 | Oxaliplatin (5.0 mg/ml) | >240 |
| 39 | Paclitaxel (Taxol), (6.0 mg/ml) | >240 |
| 40 | Paraplatin (10.0 mg/ml) | >240 |
| 41 | Pemetrexed (25.0 mg/ml) | >240 |
| 42 | Pertuzumab (30.0 mg/ml) | >240 |
| 43 | Raltitrexed (0.5 mg/ml) | >240 |
| 44 | Retrovir (10.0 mg/ml) | >240 |
| 45 | Rituximab (10.0 mg/ml) | >240 |
| 46 | Temsirolimus (25.0 mg/ml) | >240 |
| 47 | Thiotepa (10.0 mg/ml) | 13.6 |
| 48 | Topotecan HCl (1.0 mg/ml) | >240 |
| 49 | Trastuzumab (21.0 mg/ml) | >240 |
| 50 | Triclosan (2.0 mg/ml) | >240 |
| 51 | Trisenox (1.0 mg/ml) | >240 |
| 52 | Vinblastine (1.0 mg/ml) | >240 |
| 53 | Vincristine Sulfate (1.0 mg/ml) | >240 |
| 54 | Vinorelbine (10.0 mg/ml) | >240 |
| 55 | Zoledronic Acid (0.8 mg/ml) | >240 |
| 56 | Fentanyl Citrate Injection (100.0mcg/2.0ml) | >240 |
Table 1 – Tested for use with 57 chemotherapy and other liguid hazardous drugs
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
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Image /page/7/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'EG' in a stylized, interconnected design, with the 'E' in a larger, bolder font than the 'G'. The letters are colored in yellow and are set against a blue background that resembles the shape of a hand. The words 'EVER GLOBAL' are written above the letters, and 'ENTERPRISE CORP.' is written below.
Long Thanh Industrial Zone, Taman Village, Dong NAI 810000 VIETNAM TEL: (0251) 896 6676 FAX: (0251)351 4023 024 EMAIL: INFO@EGVNC0.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY
Premarket Notification 510(k)
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'E', 'G', and 'C' in a stylized, overlapping design. The letters are in yellow and are set against a blue background. The words 'EVER GLOBAL' are at the top of the logo, and 'ENTERPRISE CORP.' is at the bottom.
RIAL ZONE, TAMAN VILLAGE, DONG (0251)351 402
510(k) SUMMARY
Warning: do not use with Carmustine and Thiotepa.
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 | 21.5 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 13.6 minutes |
Xylazine Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Xylazine HCl Injection (100.0 mg/ml) was found to have no breakthrough detected for up to 240 minutes.
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 andFentanyl Citrate | Disposable Powder Free NitrileExamination Glove, Blue Color,Tested For Use WithChemotherapy Drugs andFentanyl Citrate and Xylazine | similar |
| 510(K) No. | K193555 | K244034 | n/a |
| Product Owner | Ever Global (Vietnam) EnterpriseCorporation | Ever Global (Vietnam) EnterpriseCorporation | same |
| Product Code | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Indications forUse | The nitrile powder free patientexamination glove is a non-steriledisposable device intended formedical purposes that is worn onthe examiner's hands or finger toprevent contamination betweenpatient and examiner. In addition. | The nitrile powder free patientexamination glove is a non-steriledisposable device intended formedical purposes that is worn onthe examiner's hands or finger toprevent contamination betweenpatient and examiner. In addition. | similar |
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'FG' in yellow, with the 'F' being larger than the 'G'. The letters are set against a blue background that resembles a hand. The words 'EVER GLOBAL' are at the top of the logo, and 'ENTERPRISE CORP.' is at the bottom.
Long Thanh Industrial Zone, Taman Village, Dong NAI 810000 VIETNAM TEL: (0251) 896 6676 FAX: (0251)351 4023 024 EMAIL: INFO@EGVNC0.COM FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY
| these gloves were tested for usewith chemotherapy drugs andfentanyl citrate in accordancewith ASTM D6978-05 standardpractice for assessment ofmedical gloves to permeation bychemotherapy drugs. | these gloves were tested for usewith chemotherapy drugs andfentanyl citrate and xylazine inaccordance with ASTM D6978-05 standard practice forassessment of medical gloves topermeation by chemotherapydrugs. | ||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||
| Shelf life | No | No | same | ||||
| Dimensions-Length | Complies with ASTM D6319-10Short cuff ≥230mmLong cuff ≥300mm | Complies with ASTM D6319-19Short cuff ≥230mmLong cuff ≥300mm | same | ||||
| 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 mmCuff ≥ 0.05 mm | Complies with ASTM D6319-19Palm ≥0.05 mm;Finger ≥0.05 mmCuff ≥ 0.05 mm | same | ||||
| PhysicalProperties | Complies with ASTM D6319-10Tensile StrengthBefore aging≥14MPaAfter aging ≥14MPaComplies with ASTM D6319-10Elongation:Before Aging: ≥500%After Aging: ≥400% | Complies with ASTM D6319-19Tensile StrengthBefore aging≥14MPaAfter aging ≥14MPaComplies with ASTM D6319-19Elongation:Before Aging: ≥ 500%After Aging: ≥400% | same | ||||
| Residualpowder | Complies with ASTM D6319-10< 2mg per glove | Complies with ASTM D6319-19< 2mg per glove | same | ||||
| Freedom fromHoles | In accordance with ASTMD6319-10 (G-1 with AQL 2.5) | In accordance with ASTMD6319-19 (G-1 with AQL 2.5) | same | ||||
| Biocompatibility | AAMI/ANSI/ISO 10993-10 &AAMI/ANSI/ISO 10993-5 PassesNot a skin irritant, Not a skinsensitizer & No cytotoxicityreaction | AAMI/ANSI/ISO 10993-10 &AAMI/ANSI/ISO 10993-5 PassesNot a skin irritant, Not a skinsensitizer & No cytotoxicityreaction | same | ||||
| Resistance ofGloves toPermeation byChemotherapyDrugs | no.1 | Test ChemotherapyDrug andConcentrationArsenic Trioxide(1.0 mg/ml) | MinimumBreakthroughDetectionTime (Min.)>240 | similar | no.1 | Test ChemotherapyDrug andConcentrationArsenic Trioxide(1.0 mg/ml) | MinimumBreakthroughDetectionTime (Min.)>240 |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'EG' in a stylized, golden font, superimposed over a blue background that resembles a hand. The words 'EVER GLOBAL' are printed above the letters, and 'ENTERPRISE CORP.' is printed below.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG NAI 810000 VIETNAM FAX: (0251)351 4023 024 TEL: (0251) 896 6676 FMAIL . INFO@EGVNC0 COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY
| 2 | Azacitidine (Vidaza)(25.0 mg/ml) | >240 | 2 | Azacitidine (Vidaza)(25.0 mg/ml) | >240 |
|---|---|---|---|---|---|
| 3 | Bendamustine HCl(5.0 mg/ml) | >240 | 3 | Bendamustine HCl(5.0 mg/ml) | >240 |
| 4 | Bleomycin Sulfate(15.0 mg/ml) | >240 | 4 | Bleomycin Sulfate(15.0 mg/ml) | >240 |
| 5 | Bortezomib(Velcade) (1.0mg/ml) | >240 | 5 | Bortezomib(Velcade) (1.0mg/ml) | >240 |
| 6 | Busulfan (6.0mg/ml) | >240 | 6 | Busulfan (6.0mg/ml) | >240 |
| 7 | Carboplatin (10.0mg/ml) | >240 | 7 | Carboplatin (10.0mg/ml) | >240 |
| 8 | Carfilzomib (2.0mg/ml) | >240 | 8 | Carfilzomib (2.0mg/ml) | >240 |
| 9 | Carmustine(BCNU), (3.3mg/ml) | 6.2 | 9 | Carmustine(BCNU), (3.3mg/ml) | 21.5 |
| 10 | Cetuximab (Erbitux)(2.0 mg/ml) | >240 | 10 | Cetuximab (Erbitux)(2.0 mg/ml) | >240 |
| 11 | Chloroquine (50.0mg/ml) | >240 | 11 | Chloroquine (50.0mg/ml) | >240 |
| 12 | Cisplatin (1.0mg/ml) | >240 | 12 | Cisplatin (1.0mg/ml) | >240 |
| 13 | Cladribine (1.0mg/ml) | >240 | 13 | Cladribine (1.0mg/ml) | >240 |
| 14 | Cyclophosphamide(20.0 mg/ml) | >240 | 14 | Cyclophosphamide(20.0 mg/ml) | >240 |
| 15 | Cyclosporin A(100.0 mg/ml) | >240 | 15 | Cyclosporin A(100.0 mg/ml) | >240 |
| 16 | Cytarabine (100.0mg/ml) | >240 | 16 | Cytarabine (100.0mg/ml) | >240 |
| 17 | Cytovene(Ganciclovir) (10.0mg/ml) | >240 | 17 | Cytovene(Ganciclovir) (10.0mg/ml) | >240 |
| 18 | Dacarbazine(DTIC), (10.0mg/ml) | >240 | 18 | Dacarbazine(DTIC), (10.0mg/ml) | >240 |
| 19 | Daunorubicin (5.0mg/ml) | >240 | 19 | Daunorubicin (5.0mg/ml) | >240 |
| 20 | Decitabine (5.0mg/ml) | >240 | 20 | Decitabine (5.0mg/ml) | >240 |
| 21 | Docetaxel (10.0mg/ml) | >240 | 21 | Docetaxel (10.0mg/ml) | >240 |
| 22 | DoxorubicinHydrochloride(2.0mg/ml) | >240 | 22 | DoxorubicinHydrochloride(2.0mg/ml) | >240 |
| 23 | Epirubicin (Ellence)(2.0 mg/ml) | >240 | 23 | Epirubicin (Ellence)(2.0 mg/ml) | >240 |
| 24 | Etoposide, (20.0mg/ml) | >240 | 24 | Etoposide, (20.0mg/ml) | >240 |
| 25 | Fludarabine (25.0mg/ml) | >240 | 25 | Fludarabine (25.0mg/ml) | >240 |
| 26 | Fluorouracil, (50.0mg/ml) | >240 | 26 | Fluorouracil, (50.0mg/ml) | >240 |
| 27 | Fulvestrant (50.0mg/ml) | >240 | 27 | Fulvestrant (50.0mg/ml) | >240 |
| 28 | Gemcitabine (38.0mg/ml) | >240 | 28 | Gemcitabine (38.0mg/ml) | >240 |
| 29 | Idaribicin (1.0mg/ml) | >240 | 29 | Idaribicin (1.0mg/ml) | >240 |
| 30 | Ifosfamide (50.0mg/ml) | >240 | 30 | Ifosfamide (50.0mg/ml) | >240 |
| 31 | Irinotecan (20.0mg/ml) | >240 | 31 | Irinotecan (20.0mg/ml) | >240 |
| 32 | MechlorethamineHCl (1.0 mg/ml) | >240 | 32 | MechlorethamineHCl (1.0 mg/ml) | >240 |
| 33 | Melphalan (5.0mg/ml) | >240 | 33 | Melphalan (5.0mg/ml) | >240 |
| 34 | Methotrexate (25mg/ml) | >240 | 34 | Methotrexate (25mg/ml) | >240 |
| 35 | Mesna (100 mg/ml) | >240 | 35 | Mesna (100 mg/ml) | >240 |
| 36 | Mitomycin C (0.5mg/ml) | >240 | 36 | Mitomycin C (0.5mg/ml) | >240 |
| 37 | Mitoxantrone (2.0mg/ml) | >240 | 37 | Mitoxantrone (2.0mg/ml) | >240 |
| 38 | Oxaliplatin (5.0mg/ml) | >240 | 38 | Oxaliplatin (5.0mg/ml) | >240 |
| 39 | Paclitaxel (Taxol),(6.0 mg/ml) | >240 | 39 | Paclitaxel (Taxol),(6.0 mg/ml) | >240 |
| 40 | Paraplatin (10.0mg/ml) | >240 | 40 | Paraplatin (10.0mg/ml) | >240 |
| 41 | Pemetrexed (25.0mg/ml) | >240 | 41 | Pemetrexed (25.0mg/ml) | >240 |
| 42 | Pertuzumab (30.0mg/ml) | >240 | 42 | Pertuzumab (30.0mg/ml) | >240 |
| 43 | Raltitrexed (0.5mg/ml) | >240 | 43 | Raltitrexed (0.5mg/ml) | >240 |
| 44 | Retrovir (10.0mg/ml) | >240 | 44 | Retrovir (10.0mg/ml) | >240 |
| 45 | Rituximab (10.0mg/ml) | >240 | 45 | Rituximab (10.0mg/ml) | >240 |
| 46 | Temsirolimus (25.0mg/ml) | >240 | 46 | Temsirolimus (25.0mg/ml) | >240 |
| 47 | Thiotepa (10.0mg/ml) | 13.6 | 47 | Thiotepa (10.0mg/ml) | 13.6 |
| 48 | Topotecan HCl (1.0mg/ml) | >240 | 48 | Topotecan HCl (1.0mg/ml) | >240 |
| 49 | Trastuzumab (21.0mg/ml) | >240 | 49 | Trastuzumab (21.0mg/ml) | >240 |
| 50 | Triclosan (2.0mg/ml) | >240 | 50 | Triclosan (2.0mg/ml) | >240 |
| 51 | Trisenox (1.0mg/ml) | >240 | 51 | Trisenox (1.0mg/ml) | >240 |
| 52 | Vinblastine (1.0mg/ml) | >240 | 52 | Vinblastine (1.0mg/ml) | >240 |
| 53 | Vincristine Sulfate(1.0 mg/ml) | >240 | 53 | Vincristine Sulfate(1.0 mg/ml) | >240 |
| 54 | Vinorelbine (10.0mg/ml) | >240 | 54 | Vinorelbine (10.0mg/ml) | >240 |
| 55 | Zoledronic Acid (0.8mg/ml) | >240 | 55 | Zoledronic Acid (0.8mg/ml) | >240 |
| 56 | Fentanyl CitrateInjection, (100mcg/2ml) | >240 | 56 | Fentanyl CitrateInjection, (100mcg/2ml) | >240 |
| 57 | Xylazine HCl (100mg/ml) | >240 |
Premarket Notification 510(k) Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features a large, stylized "EG" in yellow, set against a blue background that resembles a hand. The words "EVER GLOBAL" are at the top of the logo, and "ENTERPRISE CORP." is at the bottom, both in a smaller font size.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG NAI 810000 VIETNAM FAX: (0251)351 4023 024 TEL: (0251) 896 6676 MAIL . INFO@EGVNCO COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'EG' in a stylized, interconnected design, with the 'E' being larger and more prominent than the 'G'. The letters are in a bright yellow color, and they are set against a blue background that resembles a hand. The words 'EVER GLOBAL' are written in black at the top of the logo, and 'ENTERPRISE CORP.' is written in black at the bottom.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG FAX: (0251)351 4023 024
SUPERIEURVIETNAM
510(k) SUMMARY
8.0 Assessment of Non-Clinical Performance Data:
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine met the predetermined acceptance criteria. No new safety or performance issues were raised during testing:
| Test | Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D6319-19 | Determine thegeometricaldimension of gloves | Length:Short cuff: ≥230mmLong cuff: ≥300mmThickness:Palm: ≥ 0.05 mmFinger: ≥ 0.05 mmCuff: ≥ 0.05 mmPalm Width:XS: 70 ± 10 mmS: 80 ± 10 mmM: 95 ± 10 mmL: 110 ± 10 mmXL: 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(Before aging/After aging) | ASTM D6319-19 | Evaluate the tensile(tenson) properties ofthe gloves. Inaddition, it alsodetermines theinfluence of elevated | Before Aging: ≥14MPaAfter Aging: ≥14MPa | Pass |
| Elongation (Beforeaging/ After aging) | ASTM D6319-19 | temperature on thephysical properties ofgloves. | Before Aging: ≥500%After Aging: ≥400% | Pass |
| Powder Residual | ASTM D6319-19 | Determine theaverage powder massfound on the gloves | < 2mg per glove | Pass |
| Biocompatibility-cytotoxicity | AAMI/ANSI/ISO10993-5 | Determine thecytotoxicity potentialof glove | No in vitro cytotoxic asdescribed inISO 10993-5 | Pass |
| Biocompatibility-Skin Sensitization | AAMI/ANSI/ISO | Determine thepotential of glove topromote skinsensitization afterrepeated applications | No dermal reactionsindicative of delayedcontact hypersensitivity | Pass |
| and Irritation | 10993-10 | Determine thepotential of gloves topromote skinirritation afterrepeated applications. | No skin irritation,cumulative irritationindex to be 0. | Pass |
| Resistance ofGloves toPermeation byChemotherapyDrugs | ASTM D6978-05 | Assessment ofmedical gloves topermeation bychemotherapy drugs. | The resistance of ourdevice to permeationwere challenged against57 liquid hazardousdrugs | Pass |
Premarket Notification 510(k) Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the text "EVER GLOBAL (VIETNAM) ENT. CORP" in bold, black font. The text is all uppercase. There is a line underneath the text.
Image /page/13/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'EG' in a stylized, interconnected design, with the 'E' in the upper left and the 'G' in the lower right. The letters are in yellow and are set against a blue background that appears to be a stylized hand. The words 'EVER GLOBAL' are at the top of the logo, and 'ENTERPRISE CORP' is at the bottom, both in a smaller font size.
ONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG X: (0251)351 4023 02-
510(k) SUMMARY
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, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine is as safe, as effective, and performs as well as or better than the legally marketed device, K193555.
§ 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.