Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard examination glove and its performance characteristics, with no mention of AI or ML.

Therapeutic

No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner" and provide "single use barrier protection." It is a Class I device and its primary function is protective, not therapeutic.

Diagnostic

No

Explanation: The device is a patient examination glove, intended as a barrier to prevent contamination between patient and examiner. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware medical device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The provided description clearly states the device is a "patient examination glove" intended to be worn on the hand or fingers as a barrier to prevent contamination between the patient and examiner.
Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the human body. Its function is purely a physical barrier.
Testing for Permeation: While the gloves are tested for resistance to permeation by certain substances (chemotherapy drugs, fentanyl, xylazine), this testing is related to the barrier function and protection of the wearer, not the diagnosis or analysis of a patient's condition.

The device falls under the category of a medical device, specifically a patient examination glove, but it does not meet the criteria for an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

LZA, LZC, ODO, OPJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or fingers

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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: Dimension
Test Method: ASTM D6319-19
Purpose: Determine the geometrical dimension of gloves
Acceptance Criteria:
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
Results: Pass

Test: Freedom from holes (Water leak)
Test Method: 21 CFR 800.20. & ASTM D5151-19
Purpose: Detect the holes on the gloves.
Acceptance Criteria: G-I/ AQL 2.5
Results: Pass

Test: Tensile strength (Before aging/After aging)
Test Method: ASTM D6319-19
Purpose: Evaluate the tensile (tenson) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves.
Acceptance Criteria: Before Aging: ≥14MPa; After Aging: ≥14MPa
Results: Pass

Test: Elongation (Before aging/ After aging)
Test Method: ASTM D6319-19
Purpose: Evaluate the tensile (tenson) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves.
Acceptance Criteria: Before Aging: ≥500%; After Aging: ≥400%
Results: Pass

Test: Powder Residual
Test Method: ASTM D6319-19
Purpose: Determine the average powder mass found on the gloves
Acceptance Criteria:

Regulation Number and Section

§ 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.

Summary

0

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.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

2

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

3

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)

4

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

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: (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 Hazardous Drug and Concentration Detection Time (Min.) |
|-----|------------------------- | 1 | Arsenic Trioxide (1.0 mg/ml) | 2 | Azacitidine (Vidaza) (25.0 mg/ml) | 3 | Bendamustine HCl (5.0 mg/ml) | 4 | Bleomycin Sulfate (15.0 mg/ml) | 5 | Bortezomib (Velcade) (1.0 mg/ml) | 6 | Busulfan (6.0 mg/ml) | 7 | Carboplatin (10.0 mg/ml) | 8 | Carfilzomib (2.0 mg/ml) | 9 | Carmustine (BCNU), (3.3 mg/ml) | 10 | Cetuximab (Erbitux) (2.0 mg/ml) | 11 | Chloroquine (50.0 mg/ml) | 12 | Cisplatin (1.0 mg/ml) | 13 | Cladribine (1.0 mg/ml) | 14 | Cyclophosphamide (20.0 mg/ml) | 15 | Cyclosporin A (100.0 mg/ml) | 16 | Cytarabine (100.0 mg/ml) | 17 | Cytovene (Ganciclovir) (10.0 mg/ml) | 18 | Dacarbazine (DTIC), (10.0 mg/ml) | 19 | Daunorubicin (5.0 mg/ml) | 20 | Decitabine (5.0 mg/ml) | 21 | Docetaxel (10.0 mg/ml) | 22 | Doxorubicin Hydrochloride (2.0mg/ml) | 23 | Epirubicin (Ellence) (2.0 mg/ml) | 24 | Etoposide, (20.0 mg/ml) | 25 | Fludarabine (25.0 mg/ml) | 26 | Fluorouracil, (50.0 mg/ml) | 27 | Fulvestrant (50.0 mg/ml) | 28 | Gemcitabine (38.0 mg/ml) | 29 | Idaribicin (1.0 mg/ml) | 30 | Ifosfamide (50.0 mg/ml) | 31 | Irinotecan (20.0 mg/ml) | 32 | Mechlorethamine HCl (1.0 mg/ml) | 33 | Melphalan (5.0 mg/ml) | 34 | Methotrexate (25 mg/ml) | 35 | Mesna (100 mg/ml) | 36 | Mitomycin C (0.5 mg/ml) | 37 | Mitoxantrone (2.0 mg/ml) | 38 | Oxaliplatin (5.0 mg/ml) | 39 | Paclitaxel (Taxol), (6.0 mg/ml) | 40 | Paraplatin (10.0 mg/ml) | 41 | Pemetrexed (25.0 mg/ml) | 42 | Pertuzumab (30.0 mg/ml) | 43 | Raltitrexed (0.5 mg/ml) | 44 | Retrovir (10.0 mg/ml) | 45 | Rituximab (10.0 mg/ml) | 46 | Temsirolimus (25.0 mg/ml) | 47 | Thiotepa (10.0 mg/ml) | 48 | Topotecan HCl (1.0 mg/ml) | 49 | Trastuzumab (21.0 mg/ml) | 50 | Triclosan (2.0 mg/ml) | 51 | Trisenox (1.0 mg/ml) | 52 | Vinblastine (1.0 mg/ml) | 53 | Vincristine Sulfate (1.0 mg/ml) | 54 | Vinorelbine (10.0 mg/ml) | 55 | Zoledronic Acid (0.8 mg/ml) | 56 | Fentanyl Citrate and Other Liquid
| Minimum Breakthrough
-------------------------------------------------|-----------------------------------------------|
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| 21.5 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| 13.6 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
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:

| 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	Disposable Powder Free Nitrile
Examination Glove, Blue Color,
Tested For Use With
Chemotherapy Drugs and
Fentanyl Citrate and Xylazine	similar
510(K) No.	K193555	K244034	n/a
Product Owner	Ever Global (Vietnam) Enterprise
Corporation	Ever Global (Vietnam) Enterprise
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
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.	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.	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 use
with chemotherapy drugs and
fentanyl citrate in accordance
with ASTM D6978-05 standard
practice for assessment of
medical gloves to permeation by
chemotherapy drugs. | 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. | | | | | |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------|----------|-----------------------------------------------------------------------------------|-------------------------------------------------------------|
| 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 D6319-10
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;
XL: 120 ± 10 mm | Complies with ASTM D6319-19
XS: 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 D6319-10
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 D6319-10
Elongation:
Before Aging: ≥500%
After Aging: ≥400% | Complies with ASTM D6319-19
Tensile Strength
Before aging≥14MPa
After aging ≥14MPa
Complies with ASTM D6319-19
Elongation:
Before Aging: ≥ 500%
After Aging: ≥400% | same | | | | |
| Residual
powder | Complies with ASTM D6319-10
240 | similar | no.
1 | Test Chemotherapy
Drug and
Concentration
Arsenic Trioxide
(1.0 mg/ml) | Minimum
Breakthrough
Detection
Time (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) (1.0
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) | 6.2 | 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 |
| 12 | Cisplatin (1.0
mg/ml) | >240 | 12 | Cisplatin (1.0
mg/ml) | >240 |
| 13 | Cladribine (1.0
mg/ml) | >240 | 13 | Cladribine (1.0
mg/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 (100.0
mg/ml) | >240 | 16 | Cytarabine (100.0
mg/ml) | >240 |
| 17 | Cytovene
(Ganciclovir) (10.0
mg/ml) | >240 | 17 | Cytovene
(Ganciclovir) (10.0
mg/ml) | >240 |
| 18 | Dacarbazine
(DTIC), (10.0
mg/ml) | >240 | 18 | Dacarbazine
(DTIC), (10.0
mg/ml) | >240 |
| 19 | Daunorubicin (5.0
mg/ml) | >240 | 19 | Daunorubicin (5.0
mg/ml) | >240 |
| 20 | Decitabine (5.0
mg/ml) | >240 | 20 | Decitabine (5.0
mg/ml) | >240 |
| 21 | Docetaxel (10.0
mg/ml) | >240 | 21 | Docetaxel (10.0
mg/ml) | >240 |
| 22 | Doxorubicin
Hydrochloride
(2.0mg/ml) | >240 | 22 | Doxorubicin
Hydrochloride
(2.0mg/ml) | >240 |
| 23 | Epirubicin (Ellence)
(2.0 mg/ml) | >240 | 23 | Epirubicin (Ellence)
(2.0 mg/ml) | >240 |
| 24 | Etoposide, (20.0
mg/ml) | >240 | 24 | Etoposide, (20.0
mg/ml) | >240 |
| 25 | Fludarabine (25.0
mg/ml) | >240 | 25 | Fludarabine (25.0
mg/ml) | >240 |
| 26 | Fluorouracil, (50.0
mg/ml) | >240 | 26 | Fluorouracil, (50.0
mg/ml) | >240 |
| 27 | Fulvestrant (50.0
mg/ml) | >240 | 27 | Fulvestrant (50.0
mg/ml) | >240 |
| 28 | Gemcitabine (38.0
mg/ml) | >240 | 28 | Gemcitabine (38.0
mg/ml) | >240 |
| 29 | Idaribicin (1.0
mg/ml) | >240 | 29 | Idaribicin (1.0
mg/ml) | >240 |
| 30 | Ifosfamide (50.0
mg/ml) | >240 | 30 | Ifosfamide (50.0
mg/ml) | >240 |
| 31 | Irinotecan (20.0
mg/ml) | >240 | 31 | Irinotecan (20.0
mg/ml) | >240 |
| 32 | Mechlorethamine
HCl (1.0 mg/ml) | >240 | 32 | Mechlorethamine
HCl (1.0 mg/ml) | >240 |
| 33 | Melphalan (5.0
mg/ml) | >240 | 33 | Melphalan (5.0
mg/ml) | >240 |
| 34 | Methotrexate (25
mg/ml) | >240 | 34 | Methotrexate (25
mg/ml) | >240 |
| 35 | Mesna (100 mg/ml) | >240 | 35 | Mesna (100 mg/ml) | >240 |
| 36 | Mitomycin C (0.5
mg/ml) | >240 | 36 | Mitomycin C (0.5
mg/ml) | >240 |
| 37 | Mitoxantrone (2.0
mg/ml) | >240 | 37 | Mitoxantrone (2.0
mg/ml) | >240 |
| 38 | Oxaliplatin (5.0
mg/ml) | >240 | 38 | Oxaliplatin (5.0
mg/ml) | >240 |
| 39 | Paclitaxel (Taxol),
(6.0 mg/ml) | >240 | 39 | Paclitaxel (Taxol),
(6.0 mg/ml) | >240 |
| 40 | Paraplatin (10.0
mg/ml) | >240 | 40 | Paraplatin (10.0
mg/ml) | >240 |
| 41 | Pemetrexed (25.0
mg/ml) | >240 | 41 | Pemetrexed (25.0
mg/ml) | >240 |
| 42 | Pertuzumab (30.0
mg/ml) | >240 | 42 | Pertuzumab (30.0
mg/ml) | >240 |
| 43 | Raltitrexed (0.5
mg/ml) | >240 | 43 | Raltitrexed (0.5
mg/ml) | >240 |
| 44 | Retrovir (10.0
mg/ml) | >240 | 44 | Retrovir (10.0
mg/ml) | >240 |
| 45 | Rituximab (10.0
mg/ml) | >240 | 45 | Rituximab (10.0
mg/ml) | >240 |
| 46 | Temsirolimus (25.0
mg/ml) | >240 | 46 | Temsirolimus (25.0
mg/ml) | >240 |
| 47 | Thiotepa (10.0
mg/ml) | 13.6 | 47 | Thiotepa (10.0
mg/ml) | 13.6 |
| 48 | Topotecan HCl (1.0
mg/ml) | >240 | 48 | Topotecan HCl (1.0
mg/ml) | >240 |
| 49 | Trastuzumab (21.0
mg/ml) | >240 | 49 | Trastuzumab (21.0
mg/ml) | >240 |
| 50 | Triclosan (2.0
mg/ml) | >240 | 50 | Triclosan (2.0
mg/ml) | >240 |
| 51 | Trisenox (1.0
mg/ml) | >240 | 51 | Trisenox (1.0
mg/ml) | >240 |
| 52 | Vinblastine (1.0
mg/ml) | >240 | 52 | Vinblastine (1.0
mg/ml) | >240 |
| 53 | Vincristine Sulfate
(1.0 mg/ml) | >240 | 53 | Vincristine Sulfate
(1.0 mg/ml) | >240 |
| 54 | Vinorelbine (10.0
mg/ml) | >240 | 54 | Vinorelbine (10.0
mg/ml) | >240 |
| 55 | Zoledronic Acid (0.8
mg/ml) | >240 | 55 | Zoledronic Acid (0.8
mg/ml) | >240 |
| 56 | Fentanyl Citrate
Injection, (100
mcg/2ml) | >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 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
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
(tenson) properties of
the gloves. In
addition, it also
determines the
influence of elevated	Before Aging: ≥14MPa
After Aging: ≥14MPa	Pass
Elongation (Before
aging/ After aging)	ASTM D6319-19	temperature on the
physical properties of
gloves.	Before Aging: ≥500%
After Aging: ≥400%	Pass
Powder Residual	ASTM D6319-19	Determine the
average powder mass
found on the gloves