Powder-Free Vinyl Exam Gloves, clear

K252505 · Basic Medical Technology, Inc. · LYZ · Aug 28, 2025 · General Hospital

Device Facts

• Record ID: K252505
• Device Name: Powder-Free Vinyl Exam Gloves, clear
• Applicant: Basic Medical Technology, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 28, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Disposable, non-sterile, ambidextrous vinyl examination glove; clear color; available in sizes S, M, L, XL. Worn by healthcare providers on hands to serve as a physical barrier preventing contamination between patient and examiner. Device is single-use. No electronic, mechanical, or software components.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D5250-19, ASTM D3767-03, ASTM D412-16, ASTM D5151-19, ASTM D6124-06, and biocompatibility testing per ISO 10993-5, ISO 10993-10, and ISO 10993-23.

Technological Characteristics

Material: Vinyl. Design: Ambidextrous, non-sterile, powder-free. Dimensions: Length ≥230mm; Palm/Finger thickness ≥0.08mm. Standards: ASTM D5250-19 (physical properties/dimensions), ASTM D5151-19 (water leak/holes), ASTM D6124-06 (residual powder), ISO 10993-5/10/23 (biocompatibility).

Indications for Use

Indicated for use by medical examiners to prevent cross-contamination between patient and examiner during medical procedures.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Disposable Vinyl Examination Glove (K220469)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

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.

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

{1}

K252505 - Prithul Bom
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-

{2}

K252505 - Prithul Bom
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

{3}

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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. | |
| 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 [e-mail] | |
| "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." | |

{4}

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: [phone]
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:**

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.

5. **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.

1 / 4

{5}

# 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 singe use | | Yes | | Yes | | Same |
| Dimension(mm) | | Length: S/M/L/XL: ≥ 230 Width: S: 85±5 M: 95±5 L: 105±5 XL: 115±5 | | Length: S/M/L/XL: ≥ 230 Width: S: 85±5 M: 95±5 L: 105±5 XL: 115±5 | | Same |
| Thickness(mm) | | Palm: ≥ 0.08 Finger: ≥ 0.08 | | Palm: ≥ 0.08 Finger: ≥ 0.08 | | Same |
| Physical properties | Before aging | Tensile strength | 11MPa, min | Tensile strength | 11MPa, min | Same |
| | | Ultimate elongation | 300%, min | Ultimate elongation | 300%, min | Same |
| | After aging | Tensile strength | 11MPa, min | Tensile strength | 11MPa, min | Same |
| | | Ultimate elongation | 300%, min | Ultimate 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 |

{6}

3 / 4

# 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 | ISO10993-23
Under the conditions of this study, the test article did not induce skin irritation. | ISO 10993-10;
Under the conditions of the study, not an irritant or a sensitizer | Similar① |
| | ISO10993-10
Under the conditions of this test, the test article did not cause skin sensitization reaction, and the sensitization positive rate was 0%. | | Same |
| | ISO10993-5
Under the conditions of this study, the test article did not show potential toxicity to L-929 cells. | Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5 | Same |

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.

{7}

# Basic Medical Technology Inc.

Table 2 - Summary of non-clinical performance testing

| Methodology | Test Performed | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| ASTM D5250-19
ASTM D3767-03 | Physical Dimensions | Length(mm)
S/M/L/XL: ≥230 | >230 / Pass |
| | | Width(mm)
S: 85±5 mm
M: 95±5 mm
L:105±5 mm
XL: 115±5 mm | S: 85-86 / Pass
M: 95-96 / Pass
L: 104-106 / Pass
XL: 115-116 / Pass |
| | | Thickness(mm)
Finger: ≥0.08mm
Palm: ≥0.08mm | Finger: 0.09-0.12 / Pass
Palm: 0.08-0.10 / Pass |
| ASTM D5250-19
ASTM D412-16 | Physical Properties | Before aging: 11MPa, min
300%, min | 14 - 22 MPa / Pass
302 – 419 % / Pass |
| | | After aging: 11MPa, min
300%, min | 14 - 21 MPa / Pass
303 – 433 % / Pass |
| ASTM D5250-19
ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D5250-19
ASTM 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.