The Disposable 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 non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D5250	Physical Dimensions Test	Length: S/M/L/XL: ≥230mm Width: S: 85±5mm; M: 95±5mm; L: 105±5mm; XL: 115±5mm Thickness: Finger: ≥0.08mm; Palm: ≥0.08mm	Length: >230mm / Pass Width: S: 84-87mm / Pass; M: 92-96mm / Pass; L: 103-106mm / Pass; XL: 112-117mm / Pass Thickness: Finger: 0.13-0.15mm / Pass; Palm: 0.09-0.12mm / Pass
ASTM D5151	Watertightness Test for Detection of Holes	AQL 2.5	0/125 / Pass
ASTM D6124	Powder Content	< 2.0mg	0.07~0.15mg / Pass
ASTM D5250	Physical properties (Before Aging)	Tensile Strength: ≥11MPa Ultimate Elongation: ≥300%	Tensile Strength: 13~~24MPa / Pass Ultimate Elongation: 347~~579% / Pass
ASTM D5250	Physical properties (After Aging)	Tensile Strength: ≥11MPa Ultimate Elongation: ≥300%	Tensile Strength: 11~~19MPa / Pass Ultimate Elongation: 340~~529 % / Pass
ISO 10993-5	Cytotoxicity	Non-Cytotoxicity: device extract is not cytotoxic. / Pass	(Reported: "device extract is not cytotoxic. / Pass")
ISO 10993-10	Irritation	Non-irritating: not an irritant. / Pass	(Reported: "not an irritant. / Pass")
ISO 10993-10	Sensitization	Non-sensitizing: not a sensitizer. / Pass	(Reported: "not a sensitizer. / Pass")

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

Sample Size:
- Watertightness Test (ASTM D5151): The result 0/125 / Pass indicates that out of 125 units tested, 0 failed, suggesting a sample size of 125 for this specific test.
- For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), the document does not explicitly state the number of samples tested for each criterion. It reports ranges for dimensions and physical properties, which usually implies multiple samples were tested, but the exact count is not given.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. The manufacturer is located in Jiujiang City, Jiangxi, China.

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)

This information is not applicable as this device is a physical examination glove, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" is established by direct measurement and standardized test methods (e.g., ASTM and ISO standards) and their inherent acceptance criteria.

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

This information is not applicable as this device is a physical examination glove. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers, needing a tie-breaker. The tests for this device involve objective measurements against established standards.

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

This information is not applicable as this device is a physical examination glove and not an AI-assisted diagnostic tool.

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

This information is not applicable as this device is a physical examination glove and does not involve any algorithms.

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 industry standards, specifically ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, and ISO 10993-10. These standards define acceptable physical properties, freedom from holes, powder content, and biocompatibility, which are directly measured and compared.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set."

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

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set" or ground truth for such a set.

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). 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.

October 8, 2022

Jiangxi Handspro Products Solutions 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: K223008

Trade/Device Name: Disposable 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: September 29, 2022 Received: September 29, 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.

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,

Clarence W. Murray, III, PhD 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

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Indications for Use

510(k) Number (if known) K223008

Device Name Disposable Vinyl Examination Gloves

Indications for Use (Describe)

The Disposable 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)

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K223008

510(k) Summary

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

1.0 Submitter's Information

JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD. Name: Address: Chuangye Avenue, Fenglin Industrial Zone of Dean County, Jiujiang City, Jiangxi, China Phone Number: +86-18616636918 Contact: Jun Yin Date of Preparation: Sep.29, 2022

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
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

5.0 Indication for Use

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The Disposable 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 non-colored vinyl examination glove. 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(K223008)	Predicated Device(K180861)	Remark
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The DISPOSABLEVINYL EXAMINATIONGLOVES is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	The Vinyl ExaminationGlove (Clear,Non-Colored) is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer.	Same
Material	Vinyl	Vinyl	Same
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Colorant	Clear	Clear	Same
LabelingInformation	Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile	Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile	Same
Dimensions(mm)	Length:S/M/L/XL: ≥230;Width:S: 85±5;M: 95±5;L: 105±5;	Length:S≥230;M≥235;L≥245;XL≥245;Width:	SimilarAnalysis 1

Table1-General Comparison

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		XL: 115±5	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	SimilarAnalysis 1
				Tensile	11MPa,min	Tensile
	Before	Strength		Strength
	Aging	UltimateElongation	300% min	UltimateElongation	380% min	SimilarAnalysis 2
PhysicalProperties
	AfterAging	TensileStrength	11MPa,min	TensileStrength	15MPa,min	SimilarAnalysis 2
		UltimateElongation	300%min	UltimateElongation	380%min	SimilarAnalysis 2
Freedom fromHoles		Be free from holes whentested in accordancewithASTMD5151AQL=2.5	Be free from holes whentested in accordancewithASTMD5151AQL=1.5	SimilarAnalysis 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
				Under conditions of thestudy, did not showpotential toxicity to L-929cells. Complies with ISO10993-5	Under conditions of thestudy, did not showpotential toxicity to L-929cells. Complies with ISO10993-5	Same

Analysis 1:

The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250.

Analysis 2:

The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250.

Analysis 3:

Freedom from holes of subject device is similar with that of the predicate, but they all meet the requirements of ASTMD5151.

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8.0 Summarv 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.

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
ASTMD5250	PhysicalDimensionsTest	Length(mm):S/M/L/XL: ≥230;Width(mm):S: 85±5;M: 95±5;L: 105±5;XL: 115±5Thickness (mm):Finger: ≥0.08Palm: ≥0.08	Length(mm):>230/Pass;Width(mm):S: 84-87 / PassM: 92-96 / PassL: 103-106/ PassXL: 112-117/ PassThickness (mm):Finger:0.13-0.15/ PassPalm:0.09-0.12/Pass
ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTMD5151 AQL 2.5	0/125 / Pass
ASTMD6124	PowderContent	Meet the requirements of ASTMD6124 < 2.0mg	0.07~0.15mg / Pass
ASTMD5250	Physicalproperties	BeforeAgingTensileStrengthUltimate	≥11MPa 13~~24MPa / Pass≥300% 347~~579% / Pass

Table 2 - Summary of non-clinical performance testing

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		Elongation
		After Aging	Tensile Strength	≥11MPa	11~19MPa / Pass
			Ultimate Elongation	≥300%	340~529 % / Pass
ISO10993-5	Cytotoxicity	Non-CytotoxicityUnder conditions of the study, device extract is not cytotoxic. / Pass
ISO10993-10	Irritation	Non-irritatingUnder the conditions of the study, not an irritant. / Pass
ISO10993-10	Sensitization	Non-sensitizingUnder conditions of the study, not a sensitizer. / 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 Glove 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.