Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine

K244034 · Ever Global (Vietnam) Enterprise Corporation · LZA · Feb 6, 2025 · General Hospital

Device Facts

• Record ID: K244034
• Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
• Applicant: Ever Global (Vietnam) Enterprise Corporation
• Product Code: LZA · General Hospital
• Decision Date: Feb 6, 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 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.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; blue color. Provides single-use barrier protection for examiner's hands/fingers to prevent cross-contamination. Tested for permeation resistance against 57 chemotherapy/hazardous drugs, fentanyl citrate, and xylazine per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is physical barrier protection; affects clinical decision-making by enabling safe handling of hazardous substances. Benefits patient/clinician by reducing exposure to hazardous drugs and contaminants.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (dimensions, physical properties, freedom from holes, powder residual) and ASTM D6978-05 (permeation resistance to 57 hazardous drugs). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Nitrile compound; non-sterile; powder-free. Dimensions and physical properties comply with ASTM D6319-19. Permeation resistance tested per ASTM D6978-05. Biocompatibility per ISO 10993-5/10. No software or energy source.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs, fentanyl citrate, and xylazine.

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 (K193555)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 [phone]

# 510(k) SUMMARY

Elizabeth Deng

909 4659188

Xylazine

Class I

K244034

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: [phone] 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 Liquid<br>Hazardous Drug and Concentration | Minimum Breakthrough<br>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 |
| 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: [phone] FAX: [phone] EMAIL: [e-mail]

#### FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM

# 510(k) SUMMARY

Premarket Notification 510(k)

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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 [phone]

# 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:

| Device<br>Characteristic | Predicate Device | Subject Device | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Name | Disposable Powder Free Nitrile<br>Examination Glove, Blue Color,<br>Tested For Use With<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Disposable Powder Free Nitrile<br>Examination Glove, Blue Color,<br>Tested For Use With<br>Chemotherapy Drugs and<br>Fentanyl Citrate and Xylazine | similar |
| 510(K) No. | K193555 | K244034 | n/a |
| Product Owner | Ever Global (Vietnam) Enterprise<br>Corporation | Ever Global (Vietnam) Enterprise<br>Corporation | 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 for<br>Use | The nitrile powder free patient<br>examination glove is a non-sterile<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hands or finger to<br>prevent contamination between<br>patient and examiner. In addition. | The nitrile powder free patient<br>examination glove is a non-sterile<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hands or finger to<br>prevent contamination between<br>patient and examiner. In addition. | similar |

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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: [phone] FAX: [phone] EMAIL: [e-mail] FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM

# 510(k) SUMMARY

| | these gloves were tested for use<br>with chemotherapy drugs and<br>fentanyl citrate in accordance<br>with ASTM D6978-05 standard<br>practice for assessment of<br>medical gloves to permeation by<br>chemotherapy drugs. | these gloves were tested for use<br>with chemotherapy drugs and<br>fentanyl citrate and xylazine in<br>accordance with ASTM D6978-<br>05 standard practice for<br>assessment of medical gloves to<br>permeation by chemotherapy<br>drugs. | | | | | |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------|----------|-----------------------------------------------------------------------------------|-------------------------------------------------------------|
| Power free | Yes | Yes | same | | | | |
| Size | XS/S/M/L/XL | XS/S/M/L/XL | same | | | | |
| Over-The-<br>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-<br>Length | Complies with ASTM D6319-10<br>Short cuff ≥230mm<br>Long cuff ≥300mm | Complies with ASTM D6319-19<br>Short cuff ≥230mm<br>Long cuff ≥300mm | same | | | | |
| Dimensions -<br>Palm Width | Complies with ASTM D6319-10<br>XS: 70 ± 10 mm;<br>S: 80 ± 10 mm;<br>M: 95 ± 10 mm;<br>L: 110 ± 10 mm;<br>XL: 120 ± 10 mm | Complies with ASTM D6319-19<br>XS: 70 ± 10 mm;<br>S: 80 ± 10 mm;<br>M: 95 ± 10 mm;<br>L: 110 ± 10 mm:<br>XL: 120 ± 10 mm | same | | | | |
| Dimensions -<br>Thickness | Complies with ASTM D6319-10<br>Palm ≥0.05 mm;<br>Finger ≥0.05 mm<br>Cuff ≥ 0.05 mm | Complies with ASTM D6319-19<br>Palm ≥0.05 mm;<br>Finger ≥0.05 mm<br>Cuff ≥ 0.05 mm | same | | | | |
| Physical<br>Properties | Complies with ASTM D6319-10<br>Tensile Strength<br>Before aging≥14MPa<br>After aging ≥14MPa<br>Complies with ASTM D6319-10<br>Elongation:<br>Before Aging: ≥500%<br>After Aging: ≥400% | Complies with ASTM D6319-19<br>Tensile Strength<br>Before aging≥14MPa<br>After aging ≥14MPa<br>Complies with ASTM D6319-19<br>Elongation:<br>Before Aging: ≥ 500%<br>After Aging: ≥400% | same | | | | |
| Residual<br>powder | Complies with ASTM D6319-10<br>< 2mg per glove | Complies with ASTM D6319-19<br>< 2mg per glove | same | | | | |
| Freedom from<br>Holes | In accordance with ASTM<br>D6319-10 (G-1 with AQL 2.5) | In accordance with ASTM<br>D6319-19 (G-1 with AQL 2.5) | same | | | | |
| Biocompatibility | AAMI/ANSI/ISO 10993-10 &<br>AAMI/ANSI/ISO 10993-5 Passes<br>Not a skin irritant, Not a skin<br>sensitizer & No cytotoxicity<br>reaction | AAMI/ANSI/ISO 10993-10 &<br>AAMI/ANSI/ISO 10993-5 Passes<br>Not a skin irritant, Not a skin<br>sensitizer & No cytotoxicity<br>reaction | same | | | | |
| Resistance of<br>Gloves to<br>Permeation by<br>Chemotherapy<br>Drugs | no.<br>1 | Test Chemotherapy<br>Drug and<br>Concentration<br>Arsenic Trioxide<br>(1.0 mg/ml) | Minimum<br>Breakthrough<br>Detection<br>Time (Min.)<br>>240 | similar | no.<br>1 | Test Chemotherapy<br>Drug and<br>Concentration<br>Arsenic Trioxide<br>(1.0 mg/ml) | Minimum<br>Breakthrough<br>Detection<br>Time (Min.)<br>>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: [phone] TEL: [phone] FMAIL . INFO@EGVNC0 COM

FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM

# 510(k) SUMMARY

| 2 | Azacitidine (Vidaza)<br>(25.0 mg/ml) | >240 | 2 | Azacitidine (Vidaza)<br>(25.0 mg/ml) | >240 |
|----|-------------------------------------------------|------|----|-------------------------------------------------|------|
| 3 | Bendamustine HCl<br>(5.0 mg/ml) | >240 | 3 | Bendamustine HCl<br>(5.0 mg/ml) | >240 |
| 4 | Bleomycin Sulfate<br>(15.0 mg/ml) | >240 | 4 | Bleomycin Sulfate<br>(15.0 mg/ml) | >240 |
| 5 | Bortezomib<br>(Velcade) (1.0<br>mg/ml) | >240 | 5 | Bortezomib<br>(Velcade) (1.0<br>mg/ml) | >240 |
| 6 | Busulfan (6.0<br>mg/ml) | >240 | 6 | Busulfan (6.0<br>mg/ml) | >240 |
| 7 | Carboplatin (10.0<br>mg/ml) | >240 | 7 | Carboplatin (10.0<br>mg/ml) | >240 |
| 8 | Carfilzomib (2.0<br>mg/ml) | >240 | 8 | Carfilzomib (2.0<br>mg/ml) | >240 |
| 9 | Carmustine<br>(BCNU), (3.3<br>mg/ml) | 6.2 | 9 | Carmustine<br>(BCNU), (3.3<br>mg/ml) | 21.5 |
| 10 | Cetuximab (Erbitux)<br>(2.0 mg/ml) | >240 | 10 | Cetuximab (Erbitux)<br>(2.0 mg/ml) | >240 |
| 11 | Chloroquine (50.0<br>mg/ml) | >240 | 11 | Chloroquine (50.0<br>mg/ml) | >240 |
| 12 | Cisplatin (1.0<br>mg/ml) | >240 | 12 | Cisplatin (1.0<br>mg/ml) | >240 |
| 13 | Cladribine (1.0<br>mg/ml) | >240 | 13 | Cladribine (1.0<br>mg/ml) | >240 |
| 14 | Cyclophosphamide<br>(20.0 mg/ml) | >240 | 14 | Cyclophosphamide<br>(20.0 mg/ml) | >240 |
| 15 | Cyclosporin A<br>(100.0 mg/ml) | >240 | 15 | Cyclosporin A<br>(100.0 mg/ml) | >240 |
| 16 | Cytarabine (100.0<br>mg/ml) | >240 | 16 | Cytarabine (100.0<br>mg/ml) | >240 |
| 17 | Cytovene<br>(Ganciclovir) (10.0<br>mg/ml) | >240 | 17 | Cytovene<br>(Ganciclovir) (10.0<br>mg/ml) | >240 |
| 18 | Dacarbazine<br>(DTIC), (10.0<br>mg/ml) | >240 | 18 | Dacarbazine<br>(DTIC), (10.0<br>mg/ml) | >240 |
| 19 | Daunorubicin (5.0<br>mg/ml) | >240 | 19 | Daunorubicin (5.0<br>mg/ml) | >240 |
| 20 | Decitabine (5.0<br>mg/ml) | >240 | 20 | Decitabine (5.0<br>mg/ml) | >240 |
| 21 | Docetaxel (10.0<br>mg/ml) | >240 | 21 | Docetaxel (10.0<br>mg/ml) | >240 |
| 22 | Doxorubicin<br>Hydrochloride<br>(2.0mg/ml) | >240 | 22 | Doxorubicin<br>Hydrochloride<br>(2.0mg/ml) | >240 |
| 23 | Epirubicin (Ellence)<br>(2.0 mg/ml) | >240 | 23 | Epirubicin (Ellence)<br>(2.0 mg/ml) | >240 |
| 24 | Etoposide, (20.0<br>mg/ml) | >240 | 24 | Etoposide, (20.0<br>mg/ml) | >240 |
| 25 | Fludarabine (25.0<br>mg/ml) | >240 | 25 | Fludarabine (25.0<br>mg/ml) | >240 |
| 26 | Fluorouracil, (50.0<br>mg/ml) | >240 | 26 | Fluorouracil, (50.0<br>mg/ml) | >240 |
| 27 | Fulvestrant (50.0<br>mg/ml) | >240 | 27 | Fulvestrant (50.0<br>mg/ml) | >240 |
| 28 | Gemcitabine (38.0<br>mg/ml) | >240 | 28 | Gemcitabine (38.0<br>mg/ml) | >240 |
| 29 | Idaribicin (1.0<br>mg/ml) | >240 | 29 | Idaribicin (1.0<br>mg/ml) | >240 |
| 30 | Ifosfamide (50.0<br>mg/ml) | >240 | 30 | Ifosfamide (50.0<br>mg/ml) | >240 |
| 31 | Irinotecan (20.0<br>mg/ml) | >240 | 31 | Irinotecan (20.0<br>mg/ml) | >240 |
| 32 | Mechlorethamine<br>HCl (1.0 mg/ml) | >240 | 32 | Mechlorethamine<br>HCl (1.0 mg/ml) | >240 |
| 33 | Melphalan (5.0<br>mg/ml) | >240 | 33 | Melphalan (5.0<br>mg/ml) | >240 |
| 34 | Methotrexate (25<br>mg/ml) | >240 | 34 | Methotrexate (25<br>mg/ml) | >240 |
| 35 | Mesna (100 mg/ml) | >240 | 35 | Mesna (100 mg/ml) | >240 |
| 36 | Mitomycin C (0.5<br>mg/ml) | >240 | 36 | Mitomycin C (0.5<br>mg/ml) | >240 |
| 37 | Mitoxantrone (2.0<br>mg/ml) | >240 | 37 | Mitoxantrone (2.0<br>mg/ml) | >240 |
| 38 | Oxaliplatin (5.0<br>mg/ml) | >240 | 38 | Oxaliplatin (5.0<br>mg/ml) | >240 |
| 39 | Paclitaxel (Taxol),<br>(6.0 mg/ml) | >240 | 39 | Paclitaxel (Taxol),<br>(6.0 mg/ml) | >240 |
| 40 | Paraplatin (10.0<br>mg/ml) | >240 | 40 | Paraplatin (10.0<br>mg/ml) | >240 |
| 41 | Pemetrexed (25.0<br>mg/ml) | >240 | 41 | Pemetrexed (25.0<br>mg/ml) | >240 |
| 42 | Pertuzumab (30.0<br>mg/ml) | >240 | 42 | Pertuzumab (30.0<br>mg/ml) | >240 |
| 43 | Raltitrexed (0.5<br>mg/ml) | >240 | 43 | Raltitrexed (0.5<br>mg/ml) | >240 |
| 44 | Retrovir (10.0<br>mg/ml) | >240 | 44 | Retrovir (10.0<br>mg/ml) | >240 |
| 45 | Rituximab (10.0<br>mg/ml) | >240 | 45 | Rituximab (10.0<br>mg/ml) | >240 |
| 46 | Temsirolimus (25.0<br>mg/ml) | >240 | 46 | Temsirolimus (25.0<br>mg/ml) | >240 |
| 47 | Thiotepa (10.0<br>mg/ml) | 13.6 | 47 | Thiotepa (10.0<br>mg/ml) | 13.6 |
| 48 | Topotecan HCl (1.0<br>mg/ml) | >240 | 48 | Topotecan HCl (1.0<br>mg/ml) | >240 |
| 49 | Trastuzumab (21.0<br>mg/ml) | >240 | 49 | Trastuzumab (21.0<br>mg/ml) | >240 |
| 50 | Triclosan (2.0<br>mg/ml) | >240 | 50 | Triclosan (2.0<br>mg/ml) | >240 |
| 51 | Trisenox (1.0<br>mg/ml) | >240 | 51 | Trisenox (1.0<br>mg/ml) | >240 |
| 52 | Vinblastine (1.0<br>mg/ml) | >240 | 52 | Vinblastine (1.0<br>mg/ml) | >240 |
| 53 | Vincristine Sulfate<br>(1.0 mg/ml) | >240 | 53 | Vincristine Sulfate<br>(1.0 mg/ml) | >240 |
| 54 | Vinorelbine (10.0<br>mg/ml) | >240 | 54 | Vinorelbine (10.0<br>mg/ml) | >240 |
| 55 | Zoledronic Acid (0.8<br>mg/ml) | >240 | 55 | Zoledronic Acid (0.8<br>mg/ml) | >240 |
| 56 | Fentanyl Citrate<br>Injection, (100<br>mcg/2ml) | >240 | 56 | Fentanyl Citrate<br>Injection, (100<br>mcg/2ml) | >240 |
| | | | 57 | Xylazine HCl (100<br>mg/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: [phone] TEL: [phone] 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: [phone]

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 the<br>geometrical<br>dimension of gloves | Length:<br>Short cuff: ≥230mm<br>Long cuff: ≥300mm<br>Thickness:<br>Palm: ≥ 0.05 mm<br>Finger: ≥ 0.05 mm<br>Cuff: ≥ 0.05 mm<br>Palm Width:<br>XS: 70 ± 10 mm<br>S: 80 ± 10 mm<br>M: 95 ± 10 mm<br>L: 110 ± 10 mm<br>XL: 120 ± 10 mm | Pass |
| Freedom from<br>holes (Water leak) | 21 CFR 800.20.<br>&<br>ASTM D5151-19 | Detect the holes on<br>the gloves. | G-I/ AQL 2.5 | Pass |
| Tensile strength<br>(Before aging/<br>After aging) | ASTM D6319-19 | Evaluate the tensile<br>(tenson) properties of<br>the gloves. In<br>addition, it also<br>determines the<br>influence of elevated | Before Aging: ≥14MPa<br>After Aging: ≥14MPa | Pass |
| Elongation (Before<br>aging/ After aging) | ASTM D6319-19 | temperature on the<br>physical properties of<br>gloves. | Before Aging: ≥500%<br>After Aging: ≥400% | Pass |
| Powder Residual | ASTM D6319-19 | Determine the<br>average powder mass<br>found on the gloves | < 2mg per glove | Pass |
| Biocompatibility-<br>cytotoxicity | AAMI/ANSI/ISO<br>10993-5 | Determine the<br>cytotoxicity potential<br>of glove | No in vitro cytotoxic as<br>described in<br>ISO 10993-5 | Pass |
| Biocompatibility-<br>Skin Sensitization | AAMI/ANSI/ISO | Determine the<br>potential of glove to<br>promote skin<br>sensitization after<br>repeated applications | No dermal reactions<br>indicative of delayed<br>contact hypersensitivity | Pass |
| and Irritation | 10993-10 | Determine the<br>potential of gloves to<br>promote skin<br>irritation after<br>repeated applications. | No skin irritation,<br>cumulative irritation<br>index to be 0. | Pass |
| Resistance of<br>Gloves to<br>Permeation by<br>Chemotherapy<br>Drugs | ASTM D6978-05 | Assessment of<br>medical gloves to<br>permeation by<br>chemotherapy drugs. | The resistance of our<br>device to permeation<br>were challenged against<br>57 liquid hazardous<br>drugs | 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: [phone] 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.