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.

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

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.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical 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."

This is a physical medical device (a glove), not a software device or an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML model validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of FDA submission.

The document assesses the device's physical properties and its resistance to permeation by various hazardous substances. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to bench testing against established ASTM and CFR standards for medical gloves.

Here's the breakdown of the relevant information from the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

The device (Disposable Powder Free Nitrile Examination Glove, Blue Color) was tested against several physical and chemical permeation standards. The acceptance criteria and results are outlined in the "Assessment of Non-Clinical Performance Data" section (Page 17-19) and the "Indications for Use" section (Page 4-5) and summarized within the "510(k) Summary" (Page 7-11).

Test	Test Method	Purpose	Acceptance Criteria	Results
Dimension	ASTM D6319-19	Determine the geometrical dimension of gloves	Length: Short cuff: ≥230mm; Long cuff: ≥300mmThickness: Palm: ≥ 0.05 mm; Finger: ≥ 0.05 mm; Cuff: ≥ 0.05 mmPalm Width: XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm	Pass
Freedom from holes (Water leak)	21 CFR 800.20. & ASTM D5151-19	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: ≥14MPaAfter Aging: ≥14MPa	Pass
Elongation (Before aging/ After aging)	ASTM D6319-19	Related to tensile properties, measures stretchiness.	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.Determine the potential of gloves to promote skin irritation after repeated applications.	No dermal reactions indicative of delayed contact hypersensitivityNo skin irritation, cumulative irritation index to be 0.	Pass
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 the device to permeation were challenged against 59 hazardous drugs and 1 non-drugs simulated solution. General Acceptance Standard (Implicit): Maintain barrier protection for a minimum period. The tables on pages 4-5 and 7-11 list Minimum Breakthrough Detection Time (Min.) for each substance. For most substances, the acceptance criterion was ">240 minutes", meaning no breakthrough occurred within the 240-minute test period. For Carmustine and Thiotepa, specific breakthrough times (21.5 and 13.6 minutes, respectively) were observed and noted as limitations/warnings.	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state numerical sample sizes for each specific test (e.g., how many gloves were tested for a burst, tensile, or permeation). However, it implies that testing was conducted according to the specified ASTM and FDA methodologies, which inherently define minimum sample sizes for material testing (e.g., AQL levels for freedom from holes).
Data Provenance: The tests are "bench testing" conducted on physical glove samples. The manufacturer is "Ever Global (Vietnam) Enterprise Corporation" from Vietnam, so the testing was likely conducted in accordance with international standards at a facility associated with the manufacturer or a certified testing lab. The data is non-clinical performance data from laboratory experiments, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As this is a physical device subject to material property and permeation testing, "ground truth" is established by adherence to physical measurement standards and chemical analysis protocols (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 for permeation). No human expert interpretation or consensus is required to establish the "truth" of a chemical breakthrough time or tensile strength value.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are relevant in subjective human interpretation tasks (e.g., radiology image reading). For objective bench testing of physical properties, results are determined by instrumentation and adherence to standardized protocols, not human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in medical imaging. This is a physical glove, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" is established through objective, standardized laboratory measurement methods as defined by the referenced ASTM (American Society for Testing and Materials) and CFR (Code of Federal Regulations) standards.
- For physical properties (Dimensions, Tensile Strength, Elongation, Powder Residual, Freedom from Holes), the ground truth is the measured physical values against the defined thresholds in ASTM D6319-19 and 21 CFR 800.20 & ASTM D5151-19.
- For chemical permeation (Resistance to Hazardous Drugs), the ground truth is the measured breakthrough time determined by chemical analysis according to ASTM D6978-05.
- For Biocompatibility, the ground truth is the biological response (cytotoxicity, dermal reactions) as measured per AAMI/ANSI/ISO 10993-5 and 10993-10 standards.

8. The sample size for the training set:

Not Applicable. This is a physical product, not a machine learning model; therefore, there is no "training set." The product's design and manufacturing process are developed through engineering and material science, not data training.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for this physical device.

Summary

FDA 510(k) Clearance Letter - K252244

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

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.

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K252244 - Elizabeth Deng Page 2

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-

Page 3

K252244 - Elizabeth Deng Page 3

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 -S

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

Page 4

FORM FDA 3881 (8/23) Page 1 of 2

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):

Tested Chemotherapy and Concentration(mg/ml) Other Liquid Hazardous Drug	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

Page 5

FORM FDA 3881 (8/23) Page 2 of 2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 6

510(k) SUMMARY (K252244)

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 1

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

Page 7

510(k) SUMMARY (K252244)

Page 2

5.0 Device Description:

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

Page 8

510(k) SUMMARY (K252244)

5.0 Device Description:

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

Page 9

510(k) SUMMARY (K252244)

Page 3

| 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 |

Page 10

510(k) SUMMARY (K252244)

Page 11

510(k) SUMMARY (K252244)

Page 4

| 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

Page 12

510(k) SUMMARY (K252244)

Page 5

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

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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

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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
Predicate Device	Subject Device
no.	Tested Chemotherapy and Other Liquid Hazardous Drug and Concentration	Minimum Breakthrough Detection Time (Min.)	no.
1	Arsenic Trioxide (1.0 mg/ml)	>240	1
2	Azacitidine (Vidaza) (25.0 mg/ml)	>240	2
3	Bendamustine HCl (5.0 mg/ml)	>240	3
4	Bleomycin Sulfate (15.0 mg/ml)	>240	4
5	Bortezomib (Velcade) (1.0 mg/ml)	>240	5
6	Busulfan (6.0 mg/ml)	>240	6
7	Carboplatin (10.0 mg/ml)	>240	7
8	Carfilzomib (2.0 mg/ml)	>240	8
9	Carmustine (BCNU), (3.3 mg/ml)	21.5	9
10	Cetuximab (Erbitux) (2.0 mg/ml)	>240	10
11	Chloroquine (50.0 mg/ml)	>240	11

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510(k) SUMMARY (K252244)

Page 6

| 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 |

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510(k) SUMMARY (K252244)

Page 7

| 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 | 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

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510(k) SUMMARY (K252244)

Page 8

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 (tenson) 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

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510(k) SUMMARY (K252244)

8.0 Assessment of Non-Clinical Performance Data:

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 (tenson) 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

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510(k) SUMMARY (K252244)

Page 10

| | | 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.

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.