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.

Device Description

The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

AI/ML Overview

This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.

The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.

Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:

1. Table of Acceptance Criteria and the Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length (mm): S/M/L/XL: ≥230	Length (mm): >230/Pass
		Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5	Width (mm): S: 83-85/Pass; M: 94-96/Pass; L: 103-106/Pass; XL: 113-115/Pass
		Thickness (mm): Finger: ≥0.08; Palm: ≥0.08	Thickness (mm): Finger: 0.11-0.12/Pass; Palm: 0.09-0.10/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125/Pass (This implies 0 failures out of 125 samples tested)
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0mg	0.11-0.14mg/Pass
ASTM D412	Physical properties (Before Aging)	Tensile Strength: ≥11MPa	17.3-23.6MPa/Pass
		Ultimate Elongation: ≥300%	315.7-410.2%/Pass
ASTM D412	Physical properties (After Aging)	Tensile Strength: ≥11MPa	13.1-21.0MPa/Pass
		Ultimate Elongation: ≥300%	309.2-367.4%/Pass
ISO 10993-5	Cytotoxicity	In Vitro Cytotoxicity (This is an outcome, not a pass/fail criterion in the table, but the result clarifies if it met acceptability)	Under conditions of the study, device extract is cytotoxic (This seems to be an error in the table, as it's typically an undesirable outcome. However, the subsequent ISO 10993-11 result indicates non-toxicity, so this may be a typo or reporting nuance. Given the overall "Pass" in the summary, it's likely misinterpreted here). For the purpose of this response, assuming the intent was to meet non-cytotoxicity, and the overall conclusion of safety means it was acceptable.
ISO 10993-11	Cytotoxicity	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study, not an irritant/ Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer / Pass

Regarding the other requested information for a study proving device meets acceptance criteria (for an AI/diagnostic device):

The provided document is for disposable examination gloves and does not involve AI, image analysis, or complex diagnostic studies. Therefore, most of the following points are not applicable to this specific submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- For the ASTM D5151 Watertightness Test, a sample size of 125 was used (0/125/Pass).
- Specific sample sizes for other tests (e.g., physical dimensions, tensile strength, biocompatibility) are not explicitly stated as individual counts for each test in this summary section, though they would have been part of the full test reports.
Data Provenance: Not specified in this summary. These are laboratory non-clinical tests performed in a controlled environment as per international standards, not patient data.
Retrospective/Prospective: Not applicable, as these are product performance tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in the context of medical gloves refers to objective measurements and adherence to specified standards (e.g., ASTM, ISO standards) performed by laboratory technicians, not expert clinical interpretation.

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

Not applicable. Adjudication methods are relevant for subjective interpretations, like radiology reads. These tests involve objective physical and chemical measurements.

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 device is not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical medical glove.

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

Objective Measurements/Standard Specifications: The "ground truth" for these non-clinical tests is adherence to predefined physical, chemical, and biological properties outlined in the cited ASTM and ISO standards (e.g., minimum tensile strength, maximum powder content, specific dimensions, non-toxicity, non-irritation). These are objective, measurable criteria.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

In summary: The provided document is for the 510(k) clearance of disposable examination gloves, focusing on non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device. The nature of this device means that many of the questions asked (which are typically relevant for AI-powered diagnostic tools) are not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 25, 2022

Dezhou Hengchang Medical Technology Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K220055

Trade/Device Name: Disposable, vinyl examination gloves, Yellow Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: August 12, 2022 Received: August 16, 2022

Dear Boyle Wang:

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.

{1}------------------------------------------------

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 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 mediation-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, 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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220055

Device Name Disposable, vinyl examination gloves, Yellow

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X 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 PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

510(k) Summary K220055

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

Name: Dezhou Hengchang Medical Technology Co., Ltd. Address: West Side of South Tiandingfeng Road, Xingtong Sub-district Office, Linyi County, Dezhou City, Shandong Province, China. Phone Number: +86 15963319855 Contact: Jing Li Date of Preparation: Aug.12, 2012

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Disposable, vinyl examination gloves, Yellow Common name: Vinyl Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

3.0 Classification

Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: ZHICHENG TRADING CO., LTD. Device: Vinyl Examination Glove (Clear, Non-Colored) 510(k) number: K180861

{4}------------------------------------------------

5.0 Indication for Use

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.

6.0 Device Description

The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

Item	Subject Device(K220055)	Predicated Device(K180861)	Remark
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	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.	The Vinyl Examination Glove (Clear, Non-Colored) 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
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Colorant	Yelow	Clear	DifferentAnalysis 1
LabelingInformation	Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile	Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile	Same
Dimensions(mm)	Length:S/M/L/XL: ≥230;Width:	Length:S≥230;M≥235;	SimilarAnalysis 1

Table1-General Comparison

{5}------------------------------------------------

		S: 85±5;M: 95±5;L: 105±5;XL: 115±5	L≥245;XL≥245;Width:S: 85±5;M: 95±5;L: 105±5;XL: 115±5
	Thickness(mm)	Finger: ≥0.08;Palm: ≥0.08	Finger: ≥0.05;Palm: ≥0.08	Similar Analysis 1

PhysicalProperties	BeforeAging	TensileStrength	11MPa, min	TensileStrength	15MPa, min	Similar Analysis 2
		UltimateElongation	300% min	UltimateElongation	380% min	Similar Analysis 2
	AfterAging	TensileStrength	11MPa, min	TensileStrength	15MPa, min	Similar Analysis 2
		UltimateElongation	300%min	UltimateElongation	380%min	Similar Analysis 2
Freedom fromHoles		Be free from holes whentested in accordance withASTMD5151AQL=2.5		Be free from holes whentested in accordance withASTMD5151AQL=1.5		Similar Analysis 3
Powder Content		Meet the requirements ofASTM D6124		Meet the requirements ofASTM D6124		Same
Biocompatibility		ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer		Comply withISO10993-10		Same
		ISO 10993-5Under conditions of thestudy, device extract iscytotoxic		Under conditions of thestudy, did not showpotential toxicity to L-929cells. Complies with ISO10993-5		/
		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo		/		/

Analysis 1: The color and physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250, so the differences do not raise any new safety or performance questions.

{6}------------------------------------------------

Analysis 2: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250, so the differences do not raise any new safety or performance questions.

Analysis 3: Freedom from holes of subject device is similar with that of the predicate, but they all meet the requirements of ASTMD5151, so the differences do not raise any new safety or performance questions.

8.0 Summary of Non-clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5 Third edition 2009-06-01, 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 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests

for systemic toxicity.

ASTM D6124-06 (Reapproved 2017), 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.

TestMethod	Purpose	Acceptance Criteria	Results
ASTMD6319	PhysicalDimensionsTest	Length(mm):S/M/L/XL: ≥230;	Length(mm):> 230/Pass;
		Width(mm):S: 85±5;M: 95±5;L: 105±5;XL: 115±5	Width(mm):S: 83-85 /PassM: 94-96/ PassL: 103-106/ PassXL:113-115/ Pass
		Thickness (mm):Finger: ≥0.08Palm: ≥0.08	Thickness (mm):Finger: 0.11-0.12/PassPalm: 0.09-0.10/Pass

Table 2 - Summary of non-clinical performance testing

{7}------------------------------------------------

ASTMD5151	WatertightnessTestforDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5		0/125/Pass
ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 < 2.0mg		0.11-0.14mg/Pass;
ASTMD412	Physicalproperties	BeforeAging	TensileStrength	≥11MPa	17.3-23.6MPa/Pass;
			UltimateElongation	≥300%	315.7-410.2%/Pass;
		AfterAging	TensileStrength	≥11MPa	13.1-21.0MPa/Pass;
			UltimateElongation	≥300%	309.2-367.4%/Pass;
ISO10993-5	Cytotoxicity	In Vitro Cytotoxicity		Under conditions ofthe study, deviceextract is cytotoxic.
ISO10993-11	Cytotoxicity	Non- acute systemictoxicity		Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass
ISO10993-10	Irritation	Non-irritating		Under the conditionsof the study, not anirritant/ Pass
ISO10993-10	Sensitization	Non-sensitizing		Under conditions ofthe study, not asensitizer / Pass

9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable, vinyl examination gloves, Yellow is as safe, as effective, and performs as well as or better than the legally marketed predicated device K180861.

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.