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.

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.

AI/ML Overview

The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.

Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical examination gloves:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Performance / Results
ASTM D5250 (Physical Dimensions Test)	To verify physical dimensions	- Length: ≥ 230mm - Width (Small): 85±5mm - Width (Medium): 95±5mm - Width (Large): 105±5mm - Width (Extra-Large): 115±5mm - Thickness (Finger): ≥ 0.08mm - Thickness (Palm): ≥ 0.08mm	Pass
ASTM D5250 (Physical Properties - Before Aging)	To determine tensile strength and ultimate elongation before aging	- Tensile Strength: ≥ 11MPa - Ultimate Elongation: ≥ 300%	Pass
ASTM D5250 (Physical Properties - After Aging)	To determine tensile strength and ultimate elongation after aging	- Tensile Strength: ≥ 11MPa - Ultimate Elongation: ≥ 300%	Pass
ASTM D5151	Freedom from pinholes	Meets the ASTM D5151 Test for AQL 2.5 requirements	Pass
ASTM D6124	Powder Residue	Meets ASTM D6124 requirements: < 2.0mg	Pass
ISO 10993-10	To determine if the device material is an irritant	Non-irritating	Under the conditions of the study, not an irritant. / Pass
ISO 10993-10	To determine if the device material is a sensitizer	Non-sensitizing	Under conditions of the study, not a sensitizer. / Pass
ISO 10993-11	To determine if the 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

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, pinholes, or biocompatibility). The tests are based on established ASTM and ISO standards, which typically specify sampling plans.

Data Provenance: The tests were conducted internally by the manufacturer, Guangdong Kingfa Sci.& Tech.Co., Ltd., in China. The documentation implies these were prospective tests conducted on the manufactured product to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device requiring expert interpretation of results. The "ground truth" for the performance of examination gloves is based on objective, quantifiable physical and chemical properties measured according to international standards (ASTM, ISO).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device requiring human adjudication of qualitative data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11). For example, tensile strength and elongation are measured directly, and biocompatibility is assessed through standardized in-vivo and in-vitro tests with specific endpoints.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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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

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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

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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 deviceK230046	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 minFinger: 0.08mm min	Palm≥0.08mmFinger tip≥0.08mm	Same
Freedom from holes	Meets requirements of the ASTMD5250-19	Meets requirements of the ASTMD5250-19	Same
Physical Properties(before aging)	Meets requirements of the ASTMD5250-19	Meets requirements of the ASTMD5250-19	Same
Physical Properties(after aging)	Meets requirements of the ASTMD5250-19	Meets requirements of the ASTMD5250-19	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 10993-10Under the conditions of the study, not anirritant and sensitizerISO 10993-11Under the condition of acute systemictoxicity test, the testarticle did not showacute systemictoxicity in vivo .Cytotoxicity isassessed via rationale.	ISO 10993-10Under the conditions of the study, not anirritant and sensitizerISO 10993-11Under the condition of acute systemictoxicity test, the testarticle did not showacute systemictoxicity in vivoCytotoxicity isassessed 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.

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Test Method	Purpose	Acceptance Criteria	Results
ASTM D5250	PhysicalDimensions Test	Length : ≥ 230mmWidth:Small: 85±5mm;Medium: 95±5mmLarge: 105±5mmExtra- Large: 115±5mm	Pass
		Thickness (mm):Finger:≥0.08Palm: ≥0.08	Pass
	Physicalproperties	BeforeAging	TensileStrength	≥11MPa	Pass
			UltimateElongation	≥300%
		AfterAging	TensileStrength	≥11MPa	Pass
			UltimateElongation	≥300%
ASTM D5151	Freedom frompinholes	Meet the ASTMrequirements D5151Test for AQL 2.5		Pass
ASTM D6124	Powder Residue	Meet ASTMrequirementsD6124< 2.0mg		Pass
ISO 10993-10	To determine ifthe finisheddevice materialis an irritant	Non-irritating		Under theconditions of thestudy, not anirritant. / Pass
ISO 10993-10	To determine ifthe finisheddevicematerial is asensitizer	Non- sensitizing		Under conditions ofthe study, not asensitizer. / 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
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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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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.