Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
Device Facts
| Record ID | K260860 |
|---|---|
| Device Name | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) |
| Applicant | Basic Medical Technology, Inc. |
| Product Code | LYZ · General Hospital |
| Decision Date | Apr 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Attributes | 3rd-Party Reviewed |
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.
Device Story
Disposable, non-sterile, powder-free vinyl examination glove; available in blue or black; sizes S, M, L, XL. Worn by healthcare examiners to provide a physical barrier against contamination between patient and examiner. Device is ambidextrous; intended for single use. Performance verified through physical dimension, tensile strength, elongation, and water leak testing. Biocompatibility confirmed via cytotoxicity, sensitization, and irritation testing.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM D5250-19 (dimensions, physical properties), ASTM D5151-19 (water leak), and ASTM D6124-06 (residual powder). Biocompatibility verified per ISO 10993-5, ISO 10993-10, and ISO 10993-23.
Technological Characteristics
Material: Vinyl. Design: Ambidextrous, non-sterile, powder-free. Dimensions: Length ≥230mm; Width 85-115mm (size dependent); Thickness ≥0.08mm. Physical properties: Tensile strength ≥11MPa, Elongation ≥300% (before/after aging). Standards: ASTM D5250-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10, ISO 10993-23.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner.
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 Powder Free Vinyl Exam Glove, Black/Blue/Purple (K220992)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
April 7, 2026
Basic Medical Technology, Inc.
% Prithul Bom
Most Responsible Person
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul, MN 55114 USA
Re: K260860
Trade/Device Name: Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class I, reserved
Product Code: LYZ
Dated: March 31, 2026
Received: March 31, 2026
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K260860 - Prithul Bom
Page 2
(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (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 Management System Regulation (QMSR) (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-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).
{2}
K260860 - Prithul Bom
Page 3
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
{3}
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K260860 | ? |
| Please provide the device trade name(s). | | ? |
| Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| Please select the types of uses (select one or both, as
applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
{4}
Basic Medical Technology Inc.
510(K) Summary
K260860
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: Amy Gao
Tel: (909) 980-1678
Date of Preparation: April 4, 2026
2. **Device information:**
Trade / Product Name: Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
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: Ever Global (Vietnam) Enterprise Corporation
Device: Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
Product code: LYZ
510(k) number: K220992
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 black and blue color. Available in four sizes—small, medium, large, and extra-large—users can choose the most suitable option.
5. **Indications for Use:**
{5}
# Basic Medical Technology Inc.
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.
## 6. Technological Characteristic Comparison Table:
Table 1: General Comparison
| Device | | Subject Device | | Predicate Device | | Result |
| --- | --- | --- | --- | --- | --- | --- |
| 510K # | | K260860 | | K220992 | | - |
| Product Name | | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | | - |
| Product Code | | LYZ | | LYZ | | Same |
| Regulation Number | | 21 CFR 880.6250 | | 21 CFR 880.6250 | | 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. | | 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. | | Same |
| Material | | Vinyl | | Vinyl | | Same |
| Powder free | | Yes | | Yes | | Same |
| Design feature | | Ambidextrous | | Ambidextrous | | Same |
| Size | | S, M, L, XL | | S, M, L, XL | | Same |
| Sterile | | Non-Sterile | | Non-Sterile | | Same |
| Color | | Black/Blue | | Black/Blue/Purple | | Different |
| Dimension(mm) | Length: S/M/L/XL: ≥230; | | Length: S/M/L/XL: ≥230; | | Same | |
| | | Width: S: 85±5 M: 95±5 L: 105±5 XL: 115±5 | | 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 |
| Residual Powder | | Meet the requirements of | | Meet the requirements of | | Same |
{6}
# Basic Medical Technology Inc.
| | ASTM D6124 ≤ 2 mg per glove | ASTM D6124 ≤ 2 mg per glove | |
| --- | --- | --- | --- |
| Biocompatibility | ISO10993-23 Under the conditions of this study, not an irritant. | ISO 10993-10:2010 (Blue &Purple Gloves) &ISO 10993-23:2021 (Black Glove) Under the conditions of this study, not an irritant. | Same for black glove |
| | ISO10993-10 Under the conditions of this test, not a sensitizer | ISO10993-10 Under the conditions of this test, not a sensitizer | Same |
| | ISO10993-5 Under the conditions of this study, did not show potential toxicity to L-929 cells. | ISO 10993-5 Under conditions of the study, did not show potential toxicity to L-929 cells. | Same |
① The subject device (Black/Blue) has different color to the predicate device (Black/Blue/Purple), but all proposed devices are conducted the biocompatibility test.
② 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:
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.
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: 86-88 / Pass M: 96-98 / Pass L: 105-107 / Pass XL: 115-117 / Pass |
| | | Thickness(mm) Finger: ≥0.08mm Palm: ≥0.08mm | Finger: 0.09-0.15 / Pass Palm: 0.08-0.10 / Pass |
| ASTM D5250-19 | Physical Properties | Before aging Tensile strength: 11MPa, min | 14 - 23 MPa / Pass |
{7}
4 / 4
# Basic Medical Technology Inc.
| ASTM D412- 16 | | ultimate elongation: 300%, min | 305 – 409 % / Pass |
| --- | --- | --- | --- |
| | | After aging
Tensile strength: 11MPa, min
ultimate elongation: 300%, min | 14 - 24 MPa / Pass
304 – 404 % / 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 | 0.27-1.2 mg / Pass |
## 8. Summary of biocompatibility testing Data
Biocompatibility tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the criteria with the following standards:
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization.
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
Table 3 - Summary of biocompatibility testing
| Methodology | Test Performed | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| 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-Cytotoxic | Under conditions of the study, the device is not cytotoxic. /Pass |
## 9. Summary of Clinical Testing:
Clinical testing is not needed for this device.
## 10. 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 K220992, Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple.
