Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Device Facts
| Record ID | K252244 |
|---|---|
| Device Name | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid |
| Applicant | Ever Global (Vietnam) Enterprise Corporation |
| Product Code | LZA · General Hospital |
| Decision Date | Aug 21, 2025 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended 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 cchemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
Device Story
Disposable, non-sterile, blue nitrile examination glove; provides single-use barrier protection for healthcare examiners. Device functions as a physical barrier to prevent contamination between patient and examiner. Tested for permeation resistance against 59 chemotherapy/hazardous drugs and simulated gastric acid mixtures per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is the physical barrier provided by the glove material. Benefits include protection against hazardous drug exposure and cross-contamination during patient examinations.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including physical properties (tensile strength, elongation), freedom from holes, biocompatibility (cytotoxicity, sensitization, irritation), and chemical permeation resistance per ASTM D6978-05.
Technological Characteristics
Nitrile compound; non-sterile; powder-free. Dimensions and physical properties comply with ASTM D6319-19. Biocompatibility per ISO 10993-5 and ISO 10993-10. Permeation resistance tested per ASTM D6978-05.
Indications for Use
Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner. Suitable for use with chemotherapy drugs, fentanyl citrate, xylazine, and gastric acid mixtures.
Regulatory Classification
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.
Predicate Devices
- Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine (K244034)
Related Devices
- K171873 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs · Zhonghong Pulin Medical Products Co., Ltd. · Nov 15, 2017
- K233560 — Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid · Eco Medi Glove Sdn. Bhd. · Feb 26, 2024
- K211003 — SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove · Showa Best Glove, Inc. · Jan 19, 2022
- K222225 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) · Hartalega NGC Sdn. Bhd. · Nov 11, 2022
- K101822 — NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS · Sgmp Co., Ltd. · Nov 19, 2010
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
August 21, 2025
Ever Global (Vietnam) Enterprise Corporation
Elizabeth Deng
U.S. Agent
Long Thanh Industrial Zone
Taman Village, Dong Nai Province 810000
Vietnam
Re: K252244
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, QDO, OPJ
Dated: July 11, 2025
Received: July 18, 2025
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252244 - Elizabeth Deng
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K252244 - Elizabeth Deng
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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,
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K252244
Device Name
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
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 cchemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
| Tested Chemotherapy and Other Liquid Hazardous Drug | Concentration(mg/ml) | Minimum Breakthrough Detection Time(Min) |
| --- | --- | --- |
| 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 |
FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services (301) 443-6740
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FORM FDA 3881 (8/23)
Page 2 of 2
PSC Publishing Services (301) 443-6740
EF
| 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 |
| 57 Xylazine HCl | 100.0 | > 240 |
| 58 Fentanyl Citrate Injection/
Simulated Gastric Acid Fluid
Mix 50/50 Solution | 100.0 mcg/ 2.0 ml | > 240 |
| 59 Simulated Gastric Acid Fluid/
Xylazine HCl Mix 50/50 Solution | 100.0 | > 240 |
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 |
| Tested Non-drugs Solution | Concentration(mg/ml) | Minimum Breakthrough Detection Time(Min) |
| --- | --- | --- |
| 01 Simulated Gastric Acid Fluid | - | > 240 |
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
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{5}
EVER GLOBAL (VIETNAM) ENT. CORP
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCG.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
## 0.0 Summary Preparation Date: August 21, 2025
## 1.0 Submitter:
Submitter's name: Ever Global (Vietnam) Enterprise Corporation
Submitter's address: Long Thanh Industrial Zone, Taman Village, Dong Nai Province, Long Thanh District, VN 810000
Phone number: 84-61-3514022
Fax number: 84-61-3514023
Name of contact person: Jerry Lin
## 2.0 US Agent:
US Representative Name: Elizabeth Deng
Company Address: 5748 Eaglewood Place
Rancho Cucamonga, California
Rancho Cucamonga, CA 91739
Telephone Number: 909 4659188
Contact Email Address: baxianunited48@yahoo.com
## 3.0 Name of the Device
Proprietary/Trade name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Common Name: Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Classification Name: Non-powdered Patient Examination Glove
Device Classification: Class I
Regulation Number: 21 CFR 880.6250
Product Code: LZA, LZC, QDO, OPJ
510(K) Number: K252244
## 4.0 Predicate device
Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine
Company name: Ever Global (Vietnam) Enterprise Corporation
510(K) Number: K244034
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
{6}
EVER GLOBAL (VIETNAM) ENT. CORP
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCG.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
## 5.0 Device Description:
“Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid” 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, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
Table 1 – Tested for use with chemotherapy and other liquid hazardous drugs
| No. | Tested Chemotherapy and Other Liquid Hazardous Drug and Concentration | Minimum Breakthrough Detection 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 |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy
Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
{7}
EVER GLOBAL (VIETNAM) ENT. CORP.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCO.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
| 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 |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy
Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Page 3
{8}
EVER GLOBAL (VIETNAM) ENT. CORP.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EGVHCG.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
| 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 |
| 57 | Xylazine HCl (100.0 mg/ml) | >240 |
| 58 | Fentanyl Citrate Injection/Simulated Gastric Acid Fluid Mix 50/50 Solution (100.0 mcg/2.0ml) | >240 |
| 59 | Simulated Gastric Acid Fluid/Xylazine HCl Mix 50/50 Solution (100.0 mg/ml) | >240 |
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 |
Table 2 – Tested for use with non-drugs solution
| No. | Tested Non-drugs Solution | Minimum Breakthrough Detection Time (Min.) |
| --- | --- | --- |
| 1 | Simulated Gastric Acid Fluid | >240 |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
{9}
EVER GLOBAL (VIETNAM) ENT. CORP.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCO.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
## 7.0 Comparison of device technological characteristics:
| Device Characteristic | Predicate Device | Subject Device | Comparison |
| --- | --- | --- | --- |
| Product Name | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | similar |
| 510(K) No. | K244034 | K252244 | n/a |
| Product Owner | Ever Global (Vietnam) Enterprise Corporation | Ever Global (Vietnam) Enterprise Corporation | same |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Indications for Use | The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl citrate and xylazine in accordance with ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs. | The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs. | similar |
| Powder 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 D6319-10 Short cuff ≥230mm Long cuff ≥300mm | Complies with ASTM D6319-19 Short cuff ≥230mm Long cuff ≥300mm | same |
| Dimensions - Palm Width | Complies with ASTM D6319-10 XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; | Complies with ASTM D6319-19 XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; | same |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Page 5
{10}
EVER GLOBAL (VIETNAM) ENT. CORP
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCO.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
| | XL: 120 ± 10 mm | | | XL: 120 ± 10 mm | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Dimensions - Thickness | Complies with ASTM D6319-10
Palm ≥0.05 mm;
Finger ≥0.05 mm
Cuff ≥ 0.05 mm | | | Complies with ASTM D6319-19
Palm ≥0.05 mm;
Finger ≥0.05 mm
Cuff ≥ 0.05 mm | | | same |
| Physical Properties | Complies with ASTM D6319-10
Tensile Strength
Before aging≥14MPa
After aging ≥14MPa | | | Complies with ASTM D6319-19
Tensile Strength
Before aging≥14MPa
After aging ≥14MPa | | | same |
| | Complies with ASTM D6319-10
Elongation:
Before Aging: ≥500%
After Aging: ≥400% | | | Complies with ASTM D6319-19
Elongation:
Before Aging: ≥ 500%
After Aging: ≥400% | | | same |
| Residual powder | Complies with ASTM D6319-10
< 2mg per glove | | | Complies with ASTM D6319-19
< 2mg per glove | | | same |
| Freedom from Holes | In accordance with ASTM D6319-10 (G-1 with AQL 2.5) | | | In accordance with ASTM D6319-19 (G-1 with AQL 2.5) | | | same |
| Biocompatibility | AAMI/ANSI/ISO 10993-10 & AAMI/ANSI/ISO 10993-5 Passes Not a skin irritant, Not a skin sensitizer & No cytotoxicity reaction | | | AAMI/ANSI/ISO 10993-10 & AAMI/ANSI/ISO 10993-5 Passes Not a skin irritant, Not a skin sensitizer & No cytotoxicity reaction | | | same |
| Resistance of Gloves to Permeation by Chemotherapy and Other Liquid Hazardous Drugs, and Non-drugs Solution | no. | Tested Chemotherapy and Other Liquid Hazardous Drug and Concentration | Minimum Breakthrough Detection Time (Min.) | no. | Tested Chemotherapy and Other Liquid Hazardous Drug and Concentration | Minimum Breakthrough Detection Time (Min.) | similar |
| | 1 | Arsenic Trioxide (1.0 mg/ml) | >240 | 1 | Arsenic Trioxide (1.0 mg/ml) | >240 | |
| | 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) (1.0 mg/ml) | >240 | 5 | Bortezomib (Velcade) (1.0 mg/ml) | >240 | |
| | 6 | Busulfan (6.0 mg/ml) | >240 | 6 | Busulfan (6.0 mg/ml) | >240 | |
| | 7 | Carboplatin (10.0 mg/ml) | >240 | 7 | Carboplatin (10.0 mg/ml) | >240 | |
| | 8 | Carfilzomib (2.0 mg/ml) | >240 | 8 | Carfilzomib (2.0 mg/ml) | >240 | |
| | 9 | Carmustine (BCNU), (3.3 mg/ml) | 21.5 | 9 | Carmustine (BCNU), (3.3 mg/ml) | 21.5 | |
| | 10 | Cetuximab (Erbitux) (2.0 mg/ml) | >240 | 10 | Cetuximab (Erbitux) (2.0 mg/ml) | >240 | |
| | 11 | Chloroquine (50.0 mg/ml) | >240 | 11 | Chloroquine (50.0 mg/ml) | >240 | |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy
Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Page 6
{11}
EVER GLOBAL (VIETNAM) ENT. CORP.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676
FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCO.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
| | 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 |
| 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 |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy
Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Page 7
{12}
EVER GLOBAL (VIETNAM) ENT. CORP.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676
FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCG.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
| | 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 mcg/2ml) | >240 |
| | 57 | Xylazine HCl (100 mg/ml) | >240 |
| | | | |
| | 58 | Fentanyl Citrate Injection/Simulated Gastric Acid Fluid Mix 50/50 Solution (100.0 mcg/2.0ml) | >240 |
| | 59 | Simulated Gastric Acid Fluid/Xylazine HCl Mix 50/50 Solution (100.0 mg/ml) | >240 |
| | no. | Tested Non-drugs Solution | Minimum Breakthrough Detection Time (Min.) |
| | 1 | Simulated Gastric Acid Fluid | >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 mcg/2ml) | >240 |
| 57 | Xylazine HCl (100 mg/ml) | >240 |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy
Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Page 8
{13}
EVER GLOBAL (VIETNAM) ENT. CORP.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EEVWCO.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
## 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, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid 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 the geometrical dimension of gloves | Length:
Short cuff: ≥230mm
Long cuff: ≥300mm
Thickness:
Palm: ≥0.05 mm
Finger: ≥0.05 mm
Cuff: ≥0.05 mm
Palm 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 | Detect the holes on the gloves. | G-I/ AQL 2.5 | Pass |
| Tensile strength (Before aging/ After aging) | ASTM D6319-19 | Evaluate the tensile (tension) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves. | Before Aging: ≥14MPa
After Aging: ≥14MPa | Pass |
| Elongation (Before aging/ After aging) | ASTM D6319-19 | | Before Aging: ≥500%
After Aging: ≥400% | Pass |
| Powder Residual | ASTM D6319-19 | Determine the average powder mass found on the gloves | < 2mg per glove | Pass |
| Biocompatibility-cytotoxicity | AAMI/ANSI/ISO 10993-5 | Determine the cytotoxicity potential of glove | No in vitro cytotoxic as described in ISO 10993-5 | Pass |
| Biocompatibility-Skin Sensitization and Irritation | AAMI/ANSI/ISO 10993-10 | Determine the potential of glove to promote skin sensitization after repeated applications | No dermal reactions indicative of delayed contact hypersensitivity | Pass |
| | | Determine the potential of gloves to | No skin irritation, cumulative irritation | Pass |
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Page 9
{14}
EVER GLOBAL (VIETNAM) ENT. CORP
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG
NAI 810000 VIETNAM
TEL: (0251) 896 6676 FAX: (0251)351 4023 024
EMAIL: INFO@EGVKCS.COM
FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
# 510(k) SUMMARY (K252244)
| | | promote skin irritation after repeated applications. | index to be 0. | |
| --- | --- | --- | --- | --- |
| Resistance of Gloves to Permeation by Chemotherapy and Other Liquid Hazardous Drugs, and Non-drugs Solution | ASTM D6978-05 | Assessment of medical gloves to permeation by chemotherapy and other liquid hazardous drugs, and non-drugs solution. | The resistance of our device to permeation were challenged against 59 hazardous drugs and 1 non-drugs simulated solution | Pass |
# 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, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid is as safe, as effective, and performs as well as or better than the legally marketed device, K244034.
Premarket Notification 510(k)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Page 10
