The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Device Description

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are pink color, non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.

The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been been tested for biocompatibility and permeability to chemotherapy drugs, Fentanyl Citrate, Gastric Acid and Xylazine in Fentanyl Citrate.

AI/ML Overview

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device submitted for FDA 510(k) clearance.

The device in question is Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate.

Acceptance Criteria and Device Performance Study

The acceptance criteria for this device are primarily based on established industry standards for medical examination gloves and specific permeation resistance tests for various chemical substances. The study conducted to prove the device meets these criteria is a series of non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Methodology	Acceptance Criteria	Reported Device Performance
Freedom From Holes	ASTM D6319-19, ASTM D5151-19	Meet requirement inspection level G-1, AQL 2.5 (ISO2859-1)	Pass
Dimension - Length	ASTM D6319-19	Minimum 220mm for size XS-S Minimum 230mm for size M-XXL	Pass
Dimension - Width	ASTM D6319-19	XS: 70±10mm S: 80±10mm M: 95±10mm L: 110±10mm XL: 120±10mm XXL: 130±10mm	Pass
Dimension - Thickness	ASTM D6319-19	Finger: 0.05mm (min) Palm: 0.05mm (min)	Pass
Physical Properties	ASTM D6319-19, ASTM D412-16	Before aging: Tensile Strength (Min 14 Mpa) Elongation (Min 500%) After aging: Tensile Strength (Min 14 Mpa) Elongation (Min 400%)	Pass (All criteria met)
Powder Residue	ASTM D6319-19, ASTM D6124-06	Not more than 2 mg per glove	Pass
Skin Irritation (Biocompatibility)	ISO10993-23:2021	Under the conditions of the study, not a primary skin irritant	Pass (Not a primary skin irritant)
Skin Sensitization (Biocompatibility)	ISO10993-10:2021	Under the conditions of the study, not a contact sensitizer	Pass (Not a contact sensitizer)
Acute Systemic Toxicity (Biocompatibility)	ISO 10993-11:2017	Under the conditions of the study, no signs of acute systemic toxicity were observed	Pass (No signs of acute systemic toxicity were observed)
Chemotherapy Drugs Permeation	ASTM D6978-05 (2023)	Minimum Breakthrough Detection Time (minutes) Carboplatin: >240 Carmustine: Varies (15.3 min reported) Cisplatin: >240 Cyclophosphamide: >240 Cytarabine HCl: >240 Dacarbazine: >240 Daunorubicin HCl: >240 Doxorubicin HCl: >240 Etoposide: >240 5-Fluorouracil: >240 Gemcitabine HCl: >240 Ifosfamide: >240 Irinotecan HCl: >240 Mechlorethamine HCl: >240 Melphalan HCl: >240 Methotrexate: >240 Mitomycin-C: >240 Mitoxantrone HCl: >240 Pacilitaxel: >240 Thiotepa: Varies (28.2 min reported)	Carboplatin: >240 min. Carmustine: 15.3 min. Cisplatin: >240 min. Cyclophosphamide: >240 min. Cytarabine HCl: >240 min. Dacarbazine: >240 min. Daunorubicin HCl: >240 min. Doxorubicin HCl: >240 min. Etoposide: >240 min. 5-Fluorouracil: >240 min. Gemcitabine HCl: >240 min. Ifosfamide: >240 min. Irinotecan HCl: >240 min. Mechlorethamine HCl: >240 min. Melphalan HCl: >240 min. Methotrexate: >240 min. Mitomycin-C: >240 min. Mitoxantrone HCl: >240 min. Pacilitaxel: >240 min. Thiotepa: 28.2 min. Note: The document explicitly states that Carmustine and Thiotepa have "extremely low permeation times" and are accompanied by a "Warning: Do not use with Carmustine and Thiotepa," indicating that the stated permeation times for these two drugs are not >240 minutes and are accepted for the specified usage.
Fentanyl, Gastric Acid, Xylazine Permeation	ASTM D6978-05 (2023)	Minimum Breakthrough Detection Time (minutes) Fentanyl Citrate Injection: >240 Simulated Gastric Acid: >240 Fentanyl Citrate:Xylazine HCl (50:50): >240	Fentanyl Citrate Injection: >240 min. Simulated Gastric Acid: >240 min. Fentanyl Citrate (50mcg/ml): Xylazine HCl (100mg/ml), 50:50: >240 min.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes (number of gloves) used for each individual test. However, it indicates that the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such tests to ensure statistical validity.

The data provenance is through non-clinical testing performed in accordance with recognized international and national standards (ASTM, ISO). This implies the data were prospectively generated for the purpose of this submission. The country of origin of the data is not specified, but the use of international standards suggests a globally accepted testing methodology.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable (N/A) as the device is a physical product (medical glove) and the performance is evaluated through objective, standardized laboratory tests (e.g., measuring permeation time, tensile strength, dimensions) rather than expert interpretation of images or clinical data. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this type of device.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reason as above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. The tests performed for this device are objective measurements.

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

This information is not applicable (N/A). This document pertains to the clearance of a physical medical device (gloves), not an AI algorithm or a diagnostic imaging device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable (N/A). As mentioned, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective, quantitative measurements obtained through standardized laboratory testing methodologies (ASTM and ISO standards). For example:

Permeation: Measured breakthrough time of specific chemicals through the glove material.
Physical Properties: Measured tensile strength, elongation, length, width, and thickness.
Biocompatibility: Observed biological responses (e.g., irritation, sensitization, systemic toxicity) in controlled in-vitro or in-vivo (animal) tests as per ISO standards.
This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on direct physical and chemical testing.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is a manufactured product that undergoes performance and biocompatibility testing. There is no "training set" in the context of machine learning. The manufacturing process is designed and validated to consistently produce gloves meeting the specified criteria.

9. How the Ground Truth for the Training Set was Established

This information is not applicable (N/A) as there is no training set for this device. The "ground truth" for the device's design and manufacturing is derived from the established standards (ASTM, ISO) that define the performance characteristics expected of such gloves. Quality control during manufacturing ensures conformity to these standards.

Summary

FDA 510(k) Clearance Letter - K251716

Page 1

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

Doc ID # 04017.08.00

August 27, 2025

Basic Medical Technology Inc.
John Zhao
General Manager
5300 Concours Street
Ontario, California 91764

Re: K251716
Trade/Device Name: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZC, LZA, OPJ, QDO
Dated: June 4, 2025
Received: June 4, 2025

Dear John Zhao:

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.

Page 2

K251716 - John Zhao
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

K251716 - John Zhao
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,

ALLAN GUAN -S

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

Page 4

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): K251716

Device Name: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

Indications for Use (Describe)

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Chemotherapy Drugs - Minimum Breakthrough Detection Time

Drug	Concentration	Time
Carboplatin	10 mg/ml	>240 min.
Carmustine	3.3 mg/ml	15.3min.
Cisplatin	1 mg/ml	>240 min.
Cyclophosphamide	20 mg/ml	>240 min.
Cytarabine HCl	100 mg/ml	>240 min.
Dacarbazine	10 mg/ml	>240 min.
Daunorubicin HCl	5 mg/ml	>240 min.
Doxorubicin HCl	2 mg/ml	>240 min.
Etoposide	20 mg/ml	>240 min.
5-Fluorouracil	50 mg/ml	>240 min.
Gemcitabine HCl	38 mg/ml	>240 min.
Ifosfamide	50 mg/ml	>240 min.
Irinotecan HCl	20 mg/ml	>240 min.
Mechlorethamine HC1	1 mg/ml	>240 min.
Melphalan HCl	5 mg/ml	>240 min.
Methotrexate	25 mg/ml	>240 min.
Mitomycin-C	0.5 mg/ml	>240 min.
Mitoxantrone HC1	2 mg/ml	>240 min.
Pacilitaxel	6 mg/ml	>240 min.
Thiotepa	10 mg/ml	28.2 min.

Fentanyl, Gastric Acid and Xylazine - Minimum Breakthrough Detection Time

Substance	Time
Fentanyl Citrate Injection, 50mcg/ml	>240 min.
Simulated Gastric Acid	>240 min.
Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50	>240 min.

*Please note that the following drugs have extremely low permeation times:
Carmustine: 15.3 minutes, Thiotepa: 28.2 minutes
Warning: Do not use with Carmustine and Thiotepa.

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.

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

Page 5

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): K251716

Device Name: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

Indications for Use (Describe)

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Chemotherapy Drugs - Minimum Breakthrough Detection Time

Drug	Concentration	Time
Carboplatin	10 mg/ml	>240 min.
Carmustine	3.3 mg/ml	15.3min.
Cisplatin	1 mg/ml	>240 min.
Cyclophosphamide	20 mg/ml	>240 min.
Cytarabine HCl	100 mg/ml	>240 min.
Dacarbazine	10 mg/ml	>240 min.
Daunorubicin HCl	5 mg/ml	>240 min.
Doxorubicin HCl	2 mg/ml	>240 min.
Etoposide	20 mg/ml	>240 min.
5-Fluorouracil	50 mg/ml	>240 min.
Gemcitabine HCl	38 mg/ml	>240 min.
Ifosfamide	50 mg/ml	>240 min.
Irinotecan HCl	20 mg/ml	>240 min.
Mechlorethamine HCl	1 mg/ml	>240 min.
Melphalan HCl	5 mg/ml	>240 min.
Methotrexate	25 mg/ml	>240 min.
Mitomycin-C	0.5 mg/ml	>240 min.
Mitoxantrone HCl	2 mg/ml	>240 min.
Pacilitaxel	6 mg/ml	>240 min.
Thiotepa	10 mg/ml	28.2 min.

Fentanyl, Gastric Acid and Xylazine - Minimum Breakthrough Detection Time

Substance	Time
Fentanyl Citrate Injection, 50mcg/ml	>240 min.
Simulated Gastric Acid	>240 min.
Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50	>240 min.

*Please note that the following drugs have extremely low permeation times:
Carmustine: 15.3 minutes, Thiotepa: 28.2 minutes
Warning: Do not use with Carmustine and Thiotepa.

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."

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

Page 6

Basic Medical Technology Inc.

510(K) Summary

K251716

1. Submission Information

Date Prepared: August 27, 2025
Submission Format: Traditional 510(k)
510(K)#: K251716

2. Submitter Information

Applicant Name: Basic Medical Technology Inc.
Address: 5300 Concours Ontario, CA 91764
Contact Person: John Zhao
Tel: (909) 980-1678
Email: hotmailtojohn@yahoo.com

3. Device Information

Trade Name: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Common Name: Nitrile Powder-Free Exam Gloves
Classification Name: Non-Powdered Patient Examination Glove
Regulation: 21 CFR 880.6250
Product Code: LZA, LZC, QDO, OPJ
Classification Panel: General Hospital
Device Class: Class I

4. Predicate Device Information

Primary Predicate Device:
Applicant: Pt. Maja Agung Latexindo
510(k) #: K212408
Trade Name: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate)

Reference Device:
Applicant: Basic Medical Technology Inc.
510(k) #: K250630

Page 7

Trade Name: Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

5. Device Description:

The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, Fentanyl Citrate, Gastric Acid and Xylazine in Fentanyl Citrate.

6. Indications for Use:

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

NO.	Chemotherapy Drugs	Minimum Breakthrough Detection Time
1	Carboplatin, 10 mg/ml	>240 min.
2	Carmustine, 3.3 mg/ml	15.3 min.
3	Cisplatin, 1 mg/ml	>240 min.
4	Cyclophosphamide, 20 mg/ml	>240 min.
5	Cytarabine HCl, 100 mg/ml	>240 min.
6	Dacarbazine, 10 mg/ml	>240 min.
7	Daunorubicin HCl, 5 mg/ml	>240 min.
8	Doxorubicin HCl, 2 mg/ml	>240 min.
9	Etoposide, 20 mg/ml	>240 min.
10	5-Fluorouracil, 50 mg/ml	>240 min.
11	Gemcitabine HCl, 38 mg/ml	>240 min.
12	Ifosfamide, 50 mg/ml	>240 min.
13	Irinotecan HCl, 20 mg/ml	>240 min.
14	Mechlorethamine HCl, 1 mg/ml	>240 min.
15	Melphalan HCl, 5 mg/ml	>240 min.
16	Methotrexate, 25 mg/ml	>240 min.
17	Mitomycin-C, 0.5 mg/ml	>240 min.
18	Mitoxantrone HCl, 2 mg/ml	>240 min.
19	Pacilitaxel, 6 mg/ml	>240 min.
20	Thiotepa, 10 mg/ml	28.2 min.

NO.	Fentanyl, Gastric Acid and Xylazine	Minimum Breakthrough Detection Time

Page 8

| 1 | Fentanyl Citrate Injection,50mcg/ml | >240 min. |
| 2 | Gastric Acid | >240 min. |
| 3 | Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50 | >240 min. |

*Please note that the following drugs have extremely low permeation times:
Carmustine: 15.3 minutes, Thiotepa: 28.2 minutes
Warning: Do not use with Carmustine and Thiotepa.

7. Comparison of Subject Device and Predicate Device:

General Comparison Table:

Device	Proposed Device	Predicate Device	Reference Device	Result
510K #	K251716	K212408	K250630	Different
Applicant Name	Basic Medical Technology Inc.	Pt. Maja Agung Latexindo	Basic Medical Technology Inc.	Same as K250630
Product Name	Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate	Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate)	Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate	Different
Product Code	LZA, LZC, QDO, OPJ	LZA, LZC, QDO, OPJ	LZA, LZC, QDO, OPJ	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	21 CFR 880.6250	Same
Device Classification	Class I	Class I	Class I	Same
Indications for use	The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.	Powder Free Nitrile Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.	Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.	Same
Powder free	Yes	Yes	Yes	Same

Page 9

Analysis: * The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color and other does not raise questions of safety and effectiveness.

Technological Characteristic Comparison Table:

Characteristics	Proposed device	Predicate device K212408	Reference Device K250630	Result
Dimension Reference standard	ASTM D6319-19			Same
Length	Min 220mm for XS, S Min 230mm for M, L, XL, XXL	Min 220mm for XS, S Min 230mm for M, L, XL, XXL	Min 220mm for XS, S Min 230mm for M, L, XL, XXL
Width	XS: 70±10 mm S: 80±10 mm M: 95±10 mm L：110±10 mm XL：120±10 mm XXL：130±10 mm	XS: 70±10 mm S: 80±10 mm M: 95±10 mm L： 110±10 mm XL：120±10 mm XXL：130±10 mm	XS: 70±10 mm S: 80±10 mm M: 95±10 mm L：110±10 mm XL：120±10 mm XXL：130±10 mm
Thickness	Palm: Min 0.05 mm Finger: Min 0.05 mm	Palm: Min 0.05 mm Finger: Min 0.05 mm	Palm: Min 0.05 mm Finger: Min 0.05 mm
Physical properties	ASTM D6319-19 ASTM D412-16			Same
Before aging
Tensile strength	Min 14MPa	Min 14MPa	Min 14MPa
Ultimate elongation	Min 500%	Min 500%	Min 500%
After aging
Tensile strength	Min 14MPa	Min 14MPa	Min 14MPa
Ultimate elongation	Min 400%	Min 400%	Min 400%
Freedom from holes	ASTM D6319-19 ASTM D5151-19			Same
	G-I, AQL2.5	G-I, AQL2.5	G-I, AQL2.5
Residual Powder	ASTM D6319-19 ASTM D6124-06			Same
	≤ 2 mg per glove	≤ 2 mg per glove	≤ 2 mg per glove
Biocompatibility				Same
Irritation	Not a primary skin irritant	Not a primary skin irritant	Not a primary skin irritant

Page 10

Chemotherapy Drugs Comparison Claim:

Chemotherapy Drugs	Minimum Breakthrough Detection Time			Result of comparison
	Proposed device	Predicate device K212408	Reference Device K250630
Carboplatin, 10 mg/ml	>240 min.	>240 min	>240 min	Same
Carmustine, 3.3 mg/ml	15.3 min.	58.3 min	11.6 min	Different
Cisplatin, 1 mg/ml	>240 min.	>240 min	>240 min	Same
Cyclophosphamide, 20 mg/ml	>240 min.	>240 min	>240 min	Same
Cytarabine HCl, 100 mg/ml	>240 min.	/	>240 min	Same as K250630
Dacarbazine, 10 mg/ml	>240 min.	>240 min	>240 min	Same
Daunorubicin HCl, 5 mg/ml	>240 min.	/	>240 min	Same as K250630
Docetaxel, 10 mg/ml	/	>240 min	/	Different
Doxorubicin HCl, 2 mg/ml	>240 min.	>240 min	>240 min	Same
Etoposide, 20 mg/ml	>240 min.	>240 min	>240 min	Same
5-Fluorouracil, 50 mg/ml	>240 min.	>240 min	>240 min	Same
Gemcitabine HCl, 38 mg/ml	>240 min.	/	>240 min	Same as K250630
Idarubicin HCl, 1 mg/ml	/	/	>240 min	Different
Ifosfamide, 50 mg/ml	>240 min.	>240 min	>240 min	Same
Irinotecan HCl, 20 mg/ml	>240 min.	/	>240 min	Same as K250630
Mechlorethamine HCl, 1 mg/ml	>240 min.	/	>240 min	Same as K250630
Melphalan HCl, 5 mg/ml	>240 min.	/	>240 min	Same as K250630
Methotrexate, 25 mg/ml	>240 min.	>240 min	>240 min	Same
Mitomycin-C, 0.5 mg/ml	>240 min.	>240 min	>240 min	Same
Mitoxantrone HCl, 2 mg/ml	>240 min.	/	>240 min	Same as K250630
Pacilitaxel, 6 mg/ml	>240 min.	>240 min	>240 min	Same
Thiotepa, 10 mg/ml	28.2 min.	119min	25.3 min	Different
Vincristine Sulfate,1 mg/ml	/	>240 min	>240 min	Different

Fentanyl, Gastric Acid and Xylazine	Minimum Breakthrough Detection Time			Result of comparison
	Proposed device	Predicate device K212408	Reference Device K250630
Fentanyl Citrate Injection,50mg/ml	>240 min.	>240 min	>240 min.	Same
Simulated Gastric Acid	>240 min.	>240 min	>240 min.	Same
Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50	>240 min.	/	>240 min.	Same as K250630

Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference does not raise questions of safety and effectiveness.

8. Summary of Non-Clinical Performance Data

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Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:

Test performed	Methodology	Acceptance Criteria	Result
Freedom From Holes	ASTM D6319-19 ASTM D5151-19	Meet requirement inspection level G- 1, AQL 2.5 (ISO2859-1)	Pass
Dimension-Length	ASTM D6319-19	Minimum 220mm for size XS-S Minimum 230mm for size M-XXL	Pass
Dimension-Width	ASTM D6319-19	XS: 70±10mm S: 80±10mm M: 95±10mm L:110±10mm XL：120±10mm XXL：130±10mm	Pass
Dimension-Thickness	ASTM D6319-19	Finger: 0.05mm (min) Palm: 0.05mm (min)	Pass
Physical properties	ASTM D6319-19 ASTM D412-16	Tensile Strength (Min14 Mpa) Elongation (Before Aging 500% and after aging 400%) Min	Pass
Powder Residue	ASTM D6319-19 ASTM D6124-06	Not more than 2 mg per glove	Pass
Skin Irritation	ISO10993-23:2021	Under the conditions of the study, not a primary skin irritant	Pass
Skin Sensitization	ISO10993-10:2021	Under the conditions of the study, not a contact sensitizer	Pass
Acute Systemic Toxicity	ISO 10993-11:2017	Under the conditions of the study, no signs of acute systemic toxicity were observed	Pass
Chemotherapy Drug	ASTM D6978-05	Refer to the above table	Pass

ASTM D6319- 19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151- 19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D412- 16 (2021), Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— Tension
ASTM D6978-05(2023), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
ISO10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation.
ISO 10993- 11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

9. Summary of Clinical Testing

Not applicable.

10. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device, Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate, is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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.