(78 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a vinyl examination glove, with no mention of AI or ML.
No
The device is an examination glove, intended to protect both patient and examiner during examinations. It does not provide any therapeutic effect or treatment.
No
The device is described as an examination glove intended for protection during examinations, not for diagnosing medical conditions.
No
The device is a physical examination glove, not a software application. The description focuses on material properties, physical dimensions, and performance testing related to a tangible product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn on the hands of examination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical characteristics of a glove (material, powder-free, non-sterile, disposable, color, size). This aligns with a protective barrier device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in those samples.
- Providing diagnostic information.
- Any reagents, calibrators, or controls typically associated with IVDs.
The device described is a standard patient examination glove, which is a Class I medical device used for barrier protection.
N/A
Intended Use / Indications for Use
The vinyl examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D5250-19, Standard Specification for Poly(vinyl chloride) Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- 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
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For . Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for ● Acute Systemic Toxicity.
Results of the tests:
- ASTM D5250 (Physical Dimensions Test): Length: ≥ 230mm, Width: Small: 85±5mm; Medium: 95±5mm, Large: 105±5mm, Extra- Large: 115±5mm. Thickness (mm): Finger:≥0.08, Palm: ≥0.08. All Passed.
- ASTM D5250 (Physical properties): Before Aging: Tensile Strength ≥11MPa; Ultimate Elongation ≥300%. After Aging: Tensile Strength ≥11MPa; Ultimate Elongation ≥300%. All Passed.
- ASTM D5151 (Freedom from pinholes): Meets the ASTM requirements D5151 Test for AQL 2.5. Passed.
- ASTM D6124 (Powder Residue): Meet ASTM requirements D6124
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 25, 2023
Guangdong Kingfa Sci.& Tech.Co., Ltd. Xiaoge Yu Manager No.28, Delong Avenue, Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K230046
Trade/Device Name: Vinyl examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: December 28, 2022 Received: January 6, 2023
Dear Xiaoge Yu:
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 (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 located 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230046
Device Name Vinyl examination gloves
Indications for Use (Describe)
The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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GUANGDONG KINGFA SCI. & TECH.CO., LTD. 510(k) summary K230046
I. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province 511545, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn Prepa
Date: March 2, 2023
II. Proposed Device
| Device Trade Name | Vinyl examination gloves |
|---|---|
| Common name: | Vinyl Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LYZ |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K213006 |
|---|---|
| Trade name: | Vinyl examination gloves |
| Common name: | Vinyl Patient Examination Glove |
| Classification: | Class I |
| Product Code: | LYZ |
| Manufacturer | Taian Hengchang Medical Technology Co.,Ltd. |
IV. Device description
The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.
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V. Indication for use
The vinyl examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device
K230046 | Predicate device
(K213006) | Discussion |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Vinyl examination gloves | Vinyl examination gloves | - |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication for use | The vinyl examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. | The 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 |
| Main Material | Vinyl | Vinyl | Same |
| Color | Clear | Clear | Same |
| Size | Small, Medium, Large, X-large | Small, Medium, Large, X-large | Same |
| Palm width | Small (85±5mm)
Medium (95±5mm)
Large (105±5mm)
X-large (115±5mm) | Small (85±5mm)
Medium (95±5mm)
Large (105±5mm)
X-large (115±5mm) | Same |
| Length | ≥230mm | ≥230mm | Same |
| Thickness | Palm: 0.08mm min
Finger: 0.08mm min | Palm≥0.08mm
Finger tip≥0.08mm | Same |
| Freedom from holes | Meets requirements of the ASTM
D5250-19 | Meets requirements of the ASTM
D5250-19 | Same |
| Physical Properties
(before aging) | Meets requirements of the ASTM
D5250-19 | Meets requirements of the ASTM
D5250-19 | Same |
| Physical Properties
(after aging) | Meets requirements of the ASTM
D5250-19 | Meets requirements of the ASTM
D5250-19 | Same |
| Powder residual | ≤2.0 mg/gloves | ≤2.0 mg/gloves | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | ISO 10993-10
Under the conditions of the study, not an
irritant and sensitizer
ISO 10993-11
Under the condition of acute systemic
toxicity test, the test
article did not show
acute systemic
toxicity in vivo .
Cytotoxicity is
assessed via rationale. | ISO 10993-10
Under the conditions of the study, not an
irritant and sensitizer
ISO 10993-11
Under the condition of acute systemic
toxicity test, the test
article did not show
acute systemic
toxicity in vivo
Cytotoxicity is
assessed via rationale. | Same |
Table 1 Comparison of Vinyl Examination Gloves
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VII. Non-Clinical Testing
Non-clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D5250-19, Standard Specification for Poly(vinyl chloride) Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- 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
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For . Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for ●
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Acute Systemic Toxicity.
|--|
| Test Method | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| ASTM D5250 | Physical | ||||
| Dimensions Test | Length : ≥ 230mm | ||||
| Width: | |||||
| Small: 85±5mm; | |||||
| Medium: 95±5mm | |||||
| Large: 105±5mm | |||||
| Extra- Large: 115±5mm | Pass | ||||
| Thickness (mm): | |||||
| Finger:≥0.08 | |||||
| Palm: ≥0.08 | Pass | ||||
| Physical | |||||
| properties | Before | ||||
| Aging | Tensile | ||||
| Strength | ≥11MPa | Pass | |||
| Ultimate | |||||
| Elongation | ≥300% | ||||
| After | |||||
| Aging | Tensile | ||||
| Strength | ≥11MPa | Pass | |||
| Ultimate | |||||
| Elongation | ≥300% | ||||
| ASTM D5151 | Freedom from | ||||
| pinholes | Meet the ASTM | ||||
| requirements D5151 | |||||
| Test for AQL 2.5 | Pass | ||||
| ASTM D6124 | Powder Residue | Meet ASTM | |||
| requirements | |||||
| D6124 |