Vinyl examination gloves
Device Facts
| Record ID | K230046 |
|---|---|
| Device Name | Vinyl examination gloves |
| Applicant | Guangdong Kingfa Sci. & Tech.Co., Ltd. |
| Product Code | LYZ · General Hospital |
| Decision Date | Mar 25, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
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.
Device Story
Vinyl examination glove; single-use; non-sterile; powder-free. Worn on hands by examiners to provide barrier protection; prevents cross-contamination between patient and examiner. Available in four sizes (S, M, L, XL). Manufactured from vinyl material. Used in clinical or home settings. Provides physical barrier; reduces risk of contamination during examinations.
Clinical Evidence
No clinical data. Bench testing only. Device performance verified against ASTM D5250-19 (physical dimensions, tensile strength, ultimate elongation), ASTM D5151-19 (freedom from holes), and ASTM D6124-06 (residual powder). Biocompatibility confirmed via ISO 10993-10 (irritation and sensitization) and ISO 10993-11 (acute systemic toxicity).
Technological Characteristics
Material: Vinyl. Form factor: Disposable, non-sterile, powder-free gloves. Sizes: S, M, L, XL. Standards: ASTM D5250-19, ASTM D3767-03, ASTM D5151-19, ASTM D6124-06. Biocompatibility: ISO 10993-10, ISO 10993-11. Connectivity: None. Energy source: None.
Indications for Use
Indicated for use as a protective barrier on the hands of examiners to prevent contamination between patient and examiner. Intended for single-use by clinicians or patients in over-the-counter settings.
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
- Vinyl examination gloves (K213006)
Submission Summary (Full Text)
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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
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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<br>K230046 | Predicate device<br>(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)<br>Medium (95±5mm)<br>Large (105±5mm)<br>X-large (115±5mm) | Small (85±5mm)<br>Medium (95±5mm)<br>Large (105±5mm)<br>X-large (115±5mm) | Same |
| Length | ≥230mm | ≥230mm | Same |
| Thickness | Palm: 0.08mm min<br>Finger: 0.08mm min | Palm≥0.08mm<br>Finger tip≥0.08mm | Same |
| Freedom from holes | Meets requirements of the ASTM<br>D5250-19 | Meets requirements of the ASTM<br>D5250-19 | Same |
| Physical Properties<br>(before aging) | Meets requirements of the ASTM<br>D5250-19 | Meets requirements of the ASTM<br>D5250-19 | Same |
| Physical Properties<br>(after aging) | Meets requirements of the ASTM<br>D5250-19 | Meets requirements of the ASTM<br>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<br>Under the conditions of the study, not an<br>irritant and sensitizer<br>ISO 10993-11<br>Under the condition of acute systemic<br>toxicity test, the test<br>article did not show<br>acute systemic<br>toxicity <i>in vivo</i> .<br>Cytotoxicity is<br>assessed via rationale. | ISO 10993-10<br>Under the conditions of the study, not an<br>irritant and sensitizer<br>ISO 10993-11<br>Under the condition of acute systemic<br>toxicity test, the test<br>article did not show<br>acute systemic<br>toxicity <i>in vivo</i><br>Cytotoxicity is<br>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<br>Dimensions Test | Length : ≥ 230mm<br>Width:<br>Small: 85±5mm;<br>Medium: 95±5mm<br>Large: 105±5mm<br>Extra- Large: 115±5mm | Pass | | |
| | | Thickness (mm):<br>Finger:≥0.08<br>Palm: ≥0.08 | Pass | | |
| | Physical<br>properties | Before<br>Aging | Tensile<br>Strength | ≥11MPa | Pass |
| | | | Ultimate<br>Elongation | ≥300% | |
| | | After<br>Aging | Tensile<br>Strength | ≥11MPa | Pass |
| | | | Ultimate<br>Elongation | ≥300% | |
| ASTM D5151 | Freedom from<br>pinholes | Meet the ASTM<br>requirements D5151<br>Test for AQL 2.5 | | Pass | |
| ASTM D6124 | Powder Residue | Meet ASTM<br>requirements<br>D6124< 2.0mg | | Pass | |
| ISO 10993-10 | To determine if<br>the finished<br>device material<br>is an irritant | Non-irritating | | Under the<br>conditions of the<br>study, not an<br>irritant. / Pass | |
| ISO 10993-10 | To determine if<br>the finished<br>device<br>material is a<br>sensitizer | Non- sensitizing | | Under conditions of<br>the study, not a<br>sensitizer. / Pass | |
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| ISO 10993-11 | To determine if the finished device material extracts pose a systemic toxic response. | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. /Pass |
|--------------|---------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------|
|--------------|---------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------|
### VIII. Clinical Testing
No clinical study is included in this submission.
#### IX. Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the Vinyl Examination Gloves are as safe, as effective, and perform as well as or better than the predicate, K213006.
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