Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

The subject device is a powder free vinyl patient examination glove, provided as non-sterile and disposable device. It is provided with clear color. Available in four sizes small, medium, large, and extra - large users can choose the most suitable option.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary describe the regulatory approval process for "Powder-Free Vinyl Exam Gloves, clear." This is a Class I medical device, and the clearance is based on demonstrating substantial equivalence to a predicate device, K220469, "Disposable Vinyl Examination Glove."

The study described is not a clinical study involving human patients or complex AI algorithms necessitating multi-reader, multi-case (MRMC) studies or expert adjudication of medical images. Instead, it's a non-clinical performance study focused on the physical, chemical, and biological properties of the gloves.

Therefore, many of the requested points related to AI performance, human reader improvement, and complex ground truth establishment for medical diagnosis are not applicable to this type of device and study.

Here's the breakdown of the information that is applicable:

Acceptance Criteria and Device Performance for Powder-Free Vinyl Exam Gloves, Clear

The acceptance criteria and device performance are primarily based on non-clinical testing according to recognized industry standards (ASTM and ISO). The goal is to demonstrate that the subject device meets the same performance specifications as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Methodology (Standard)	Test Performed	Acceptance Criteria	Reported Device Performance	Outcome
ASTM D5250-19, ASTM D3767-03	Physical Dimensions: Length	S/M/L/XL: 230 mm	230 mm	Pass
	Physical Dimensions: Width	S: 85±5 mm; M: 95±5 mm; L: 105±5 mm; XL: 115±5 mm	S: 85-86 mm; M: 95-96 mm; L: 104-106 mm; XL: 115-116 mm	Pass
	Physical Dimensions: Thickness	Finger: 0.08 mm; Palm: 0.08 mm	Finger: 0.09-0.12 mm; Palm: 0.08-0.10 mm	Pass
ASTM D5250-19, ASTM D412-16	Physical Properties: Before aging (Tensile strength)	11 MPa, min	14 - 22 MPa	Pass
	Physical Properties: Before aging (Ultimate elongation)	300%, min	302 - 419 %	Pass
	Physical Properties: After aging (Tensile strength)	11 MPa, min	14 - 21 MPa	Pass
	Physical Properties: After aging (Ultimate elongation)	300%, min	303 - 433 %	Pass
ASTM D5250-19, ASTM D5151-19	Water leak test (Freedom from holes)	G-I, AQL 2.5 (ISO 2859-1)	Pass	Pass
ASTM D5250-19, ASTM D6124-06	Powder Residue	Max 2 mg/glove	0.37-0.53 mg	Pass
ISO 10993-10:2021	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer.	Pass
ISO 10993-23:2021	Irritation	Non-irritating	Under the conditions of the study, not an irritant.	Pass
ISO 10993-5:2009	Cytotoxicity	Non-Cytotoxicity	Under conditions of the study, device is not cytotoxic.	Pass

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

Sample Size: The document does not specify a precise numerical sample size (e.g., number of gloves) for each non-clinical test. However, it indicates that testing was performed according to the specified ASTM and ISO standards, which inherently define the necessary sample sizes and methodologies for ensuring statistical validity within their respective contexts (e.g., AQL for the water leak test).
Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Basic Medical Technology Inc." is located in Ontario, CA (presumably California, USA) and the predicate device manufacturer is a Chinese company (CHIFENG HUAWEI MEDICAL SCIENCE TECHNOLOGY CO., LTD.), the testing could have been performed either in the US, China, or accredited labs elsewhere.
Retrospective or Prospective: This testing is inherently prospective as it involves the manufacturing and testing of new device samples to demonstrate compliance with standards.

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

Not Applicable: For this type of non-clinical device (medical gloves), "ground truth" is not established by medical experts interpreting images or clinical data. Instead, it's established by the physical and chemical properties of the material as measured by standardized laboratory methods. The "experts" would be the accredited laboratory personnel performing the tests according to the ASTM and ISO standards, not medical professionals like radiologists.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of complex data (like medical images). This is a physical product testing scenario where results are quantitative measurements against objective criteria, so no adjudication by multiple human observers is required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable: An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in tasks like diagnostic imaging. This device is a pair of medical gloves; there is no AI component or human reader interpretation task involved.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not Applicable: This pertains to AI algorithm performance evaluation. There is no AI algorithm in "Powder-Free Vinyl Exam Gloves, clear." The "standalone" performance here refers to the device's physical and biological properties.

7. Type of Ground Truth Used

The "ground truth" for this device is based on objective, standardized measurements of its physical properties (e.g., dimensions, tensile strength, elongation, hole detection) and biological compatibility (e.g., cytotoxicity, irritation, sensitization), as defined by internationally recognized ASTM and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm. The manufacturing process of the gloves would have its own quality control and process validation, which might involve data collection analogous to a training set for process refinement, but this is distinct from AI model training.

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

Not Applicable: As there is no AI training set, this question is irrelevant.

Summary

FDA 510(k) Clearance Letter - K252505

Page 1

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

Doc ID # 04017.08.00

August 28, 2025

Basic Medical Technology Inc.
℅ Prithul Bom
Most Responsible Person
Regulatory Technology Services, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul, Minnesota 55114

Re: K252505
Trade/Device Name: Powder-Free Vinyl Exam Gloves, clear
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class I, reserved
Product Code: LYZ
Dated: August 8, 2025
Received: August 8, 2025

Dear Prithul Bom:

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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K252505 - Prithul Bom
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K252505 - Prithul Bom
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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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): K252505

Device Name: Powder-Free Vinyl Exam Gloves, clear

Indications for Use (Describe):
Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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.

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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Basic Medical Technology Inc.

510(K) Summary K252505

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1. Submitter's Information:

Company Name: Basic Medical Technology Inc.
Address: 5300 Concours Ontario, CA 91764
Contact Person: John Zhao
Tel: (909) 980-1678
Date of Preparation: July 28, 2025

2. Device information:

Trade / Product Name: Powder-Free Vinyl Exam Gloves, clear
Common Name: Vinyl Patient Examination Glove
Classification Name: Non-Powdered Patient Examination Glove
Model(s): S, M, L, XL
Regulation: 21 CFR 880.6250
Product Code: LYZ
Classification Panel: General Hospital
Device Class: Class I

3. Predicate Device Information:

Manufacturer: CHIFENG HUAWEI MEDICAL SCIENCE TECHNOLOGY CO., LTD.
Device: Disposable Vinyl Examination Glove
Product code: LYZ
510(k) number: K220469

4. Device Description:

5. Indications for Use:

Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the

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Basic Medical Technology Inc.

6. Technological Characteristic Comparison Table:

Table 1: General Comparison

Item	Subject Device	Predicate Device(K220469)	Remark
Product Name	Powder-Free Vinyl Exam Gloves, clear	Disposable Vinyl Examination Glove	-
Product Code	LYZ	LYZ	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Indications for use	Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.	The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.	Same
Material	Vinyl	Vinyl	Same
Powder free	Yes	Yes	Same
Design feature	Ambidextrous	Ambidextrous	Same
Color	Clear	Clear	Same
Size	S, M, L, XL	S, M, L, XL	Same
Sterile	Non-Sterile	Non-Sterile	Same
For single use	Yes	Yes	Same
Dimension(mm)	Length: S/M/L/XL: 230Width:S: 85±5M: 95±5L: 105±5XL: 115±5	Length: S/M/L/XL: 230Width:S: 85±5M: 95±5L: 105±5XL: 115±5	Same
Thickness(mm)	Palm: 0.08Finger: 0.08	Palm: 0.08Finger: 0.08	Same
Physical properties	Before agingTensile strength: 11MPa, minUltimate elongation: 300%, minAfter agingTensile strength: 11MPa, minUltimate elongation: 300%, min	Before agingTensile strength: 11MPa, minUltimate elongation: 300%, minAfter agingTensile strength: 11MPa, minUltimate elongation: 300%, min	Same
Freedom from holes	Be free from holes when tested in accordance with ASTM D5151 G-I AQL=2.5	Be free from holes when tested in accordance with ASTM D5151 G-I AQL=2.5	Same

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Basic Medical Technology Inc.

Item	Subject Device	Predicate Device(K220469)	Remark
Residual Powder	Meet the requirements of ASTM D6124 ≤ 2 mg per glove	Meet the requirements of ASTM D6124 ≤ 2 mg per glove	Same
Biocompatibility	ISO10993-23Under the conditions of this study, the test article did not induce skin irritation.ISO10993-10Under the conditions of this test, the test article did not cause skin sensitization reaction, and the sensitization positive rate was 0%.ISO10993-5Under the conditions of this study, the test article did not show potential toxicity to L-929 cells.	ISO 10993-10;Under the conditions of the study, not an irritant or a sensitizerUnder conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5	Similar ①SameSame

① The new version of standard for Skin Irritation we refer is ISO 10993-23:2021, the test method and process is the same as the old version ISO 10993-10

7. Summary of Non-Clinical Performance Data

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:

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

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Basic Medical Technology Inc.

Table 2 - Summary of non-clinical performance testing

Methodology	Test Performed	Acceptance Criteria	Results
ASTM D5250-19ASTM D3767-03	Physical Dimensions	Length(mm)S/M/L/XL: 230	230 / Pass
		Width(mm)S: 85±5 mmM: 95±5 mmL:105±5 mmXL:115±5 mm	S: 85-86 / PassM: 95-96 / PassL: 104-106 / PassXL: 115-116 / Pass
		Thickness(mm)Finger: 0.08mmPalm: 0.08mm	Finger: 0.09-0.12 / PassPalm: 0.08-0.10 / Pass
ASTM D5250-19ASTM D412-16	Physical Properties	Before aging: 11MPa, min300%, min	14 - 22 MPa / Pass302 419 % / Pass
		After aging: 11MPa, min300%, min	14 - 21 MPa / Pass303 433 % / Pass
ASTM D5250-19ASTM D5151-19	Water leak test	G-I, AQL 2.5 (ISO 2859-1)	Pass
ASTM D5250-19ASTM D6124-06	Powder Residue	Max 2mg/glove	0.37-0.53mg / Pass
ISO 10993-10:2021	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer. /Pass
ISO 10993-23:2021	Irritation	Non-irritating	Under the conditions of the study, not an irritant/ Pass
ISO 10993-5:2009	Cytotoxicity	Non-Cytotoxicity	Under conditions of the study, device is not cytotoxic. /Pass

8. Summary of Clinical Testing:

Clinical testing is not needed for this device.

9. Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K220469, Disposable Vinyl Examination Glove.

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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.