The Vinyl Examination Gloves(Yellow) 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 patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

AI/ML Overview

This FDA 510(k) summary is for a Vinyl Examination Glove and does not describe an AI/ML powered medical device. Therefore, it does not include the detailed information typically associated with such device evaluations, such as studies on acceptance criteria, reader performance, or ground truth establishment.

However, I can extract the acceptance criteria and performance data for this traditional medical device based on the provided document.

Acceptance Criteria and Device Performance (Vinyl Examination Gloves):

The acceptance criteria are primarily defined by adherence to recognized international and national standards for medical gloves, and comparability to the predicate device. The performance data is presented in the context of these standards and comparisons.

Acceptance Criteria Item	Standard/Requirement	Reported Device Performance	Comparison to Predicate Device
Physical Dimensions	Length: Based on predicate device (K163168) with specific tolerance	Subject Device (K203702): Length, mm (S, M, L, XL): 240, 240, 240, 240 (±10)Predicate Device (K163168): Length, mm (XS, S, M, L, XL): 230, 230, 235, 245, 245 (min)	Similar
	Width: Based on predicate device (K163168) with specific tolerance	Subject Device (K203702): Width, mm (S, M, L, XL): 85, 95, 105, 115 (±5)Predicate Device (K163168): Width, mm (XS, S, M, L, XL): 80, 85, 95, 105, 115 (±5)	Similar
	Thickness (Finger): Based on predicate device with specific tolerance	Subject Device (K203702): Finger, mm: 0.10 (±0.05)Predicate Device (K163168): Finger, mm: 0.05 (min)	Similar
	Thickness (Palm): Based on predicate device with specific tolerance	Subject Device (K203702): Palm, mm: 0.08 (min)Predicate Device (K163168): Palm, mm: 0.08 (min)	Similar
Physical Properties	Comply with ASTM D5250 (Standard Specification for Poly (vinyl chloride) Gloves for Medical Application)	Comply with ASTM D5250	Same
Before Aging Tensile Strength	Specified by ASTM D5250 and comparable to predicate	Subject Device: 11MPa, minPredicate Device: 15MPa, min	Similar (meets ASTM D5250)
Before Aging Ultimate Elongation	Specified by ASTM D5250 and comparable to predicate	Subject Device: 300%minPredicate Device: 380%min	Similar (meets ASTM D5250)
After Aging Tensile Strength	Specified by ASTM D5250 and comparable to predicate	Subject Device: 11MPa, minPredicate Device: 15MPa, min	Similar (meets ASTM D5250)
After Aging Ultimate Elongation	Specified by ASTM D5250 and comparable to predicate	Subject Device: 300%minPredicate Device: 380%min	Similar (meets ASTM D5250)
Freedom from Holes	Be free from holes when tested in accordance with ASTM D5151 AQL=2.5	Be free from holes when tested in accordance with ASTM D5151 AQL=2.5	Same
Powder Content	Comply with ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)	Subject Device: 0.01 mg per glovePredicate Device: Meet the requirements of ASTM D6124	Similar
Biocompatibility	Irritation: Not an irritant (ISO 10993-10)	Under the conditions of the study, not an irritant	Same
	Sensitization: Not a sensitizer (ISO 10993-10)	Under conditions of the study, not a sensitizer.	Same
	Cytotoxicity: No potential toxicity to L-929 cells (ISO 10993-5)	Under conditions of the study, did not show potential toxicity to L-929 cells.	Different (lack of predicate data)
Material	Vinyl	Vinyl	Same
Labeling	Meet FDA's Requirement	Meet FDA's Requirement (Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile)	Similar

Since this document is for a traditional medical device (Vinyl Examination Gloves) and not an AI/ML powered device, the following points are not applicable or the information is not provided in the document:

Sample size used for the test set and the data provenance: The document mentions "test results" for physical and biological properties, but it does not specify the sample size for these tests. The provenance of the data is implied to be from the manufacturer (XINYING TRADING CO.,LTD.) in China, for the device manufactured there.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device. Ground truth is established by standardized testing protocols (e.g., ASTM, ISO) and laboratory results, not expert consensus in the clinical sense.
Adjudication method: Not applicable. Performance is based on objective measurements against established standards.
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 as this is not an AI/ML-powered device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is not an AI/ML-powered device.
The type of ground truth used: The "ground truth" for this device's performance is derived from compliance with recognized performance standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10, ISO 10993-5) through laboratory testing.
The sample size for the training set: Not applicable as this is not an AI/ML-powered device requiring a training set.
How the ground truth for the training set was established: Not applicable as this is not an AI/ML-powered device requiring a training set.

Summary of the Study that Proves Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed in the "Non-Clinical Test Conclusion" (Section 8.0). The device was tested for compliance with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: This standard was used to demonstrate that the glove is not an irritant or sensitizer.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity: This standard was used to show that the glove did not exhibit potential toxicity to L-929 cells.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves: This standard confirms the powder content within acceptable limits for a powder-free glove.
ASTM D5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves: This standard ensures the integrity of the gloves (freedom from holes).
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application: This is a comprehensive standard covering general physical requirements such as tensile strength, ultimate elongation, and dimensions.

The document states that the "test results demonstrated that the proposed device complies with the following standards," suggesting that the performance metrics listed in Table 3 and Table 4 were obtained through testing against these specified standards. The comparison to the predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves K163168) further supports the substantial equivalence claim by showing similar technological characteristics and performance within the established standards, even with some numerical differences in physical properties like tensile strength and elongation, which were deemed to still meet ASTM D5250 and thus not raise new safety or performance questions. Clinical testing was not deemed necessary for this device (Section 9.0).

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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2021

Xinying Trading CO., LTD. % Boyle Wang Official Correspondent Shanghai Truthful information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 Cn

Re: K203702

Trade/Device Name: 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: December 1, 2020 Received: December 18, 2020

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

For: Elizabeth F. Claverie-Williams, MS 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) K203702

Device Name Vinyl Examination Gloves(Yellow)

Indications for Use (Describe)

The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K203702

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

DATE: December 1, 2020

1.0 Submitter's Information

Name: XINYING TRADING CO.,LTD. Address: Garden Street, Dezhou City 253000, Shandong, China. Phone Number: Contact: Mr. Tongguang Liu Date of Preparation: 11/27/2020

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Vinyl Examination Gloves (Yellow) Vinyl Patient Examination Glove Common name: 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: Hebei Hongtai Plastic Products Company Limited Vinyl Patient Examination Gloves (White, Blue, Yellow) Device: 510(k) number: K163168

5.0 Indication for Use

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The Vinyl Examination Gloves (Yellow) 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

7.0 Summary Comparing Technological Characteristics with Predicate Device

Item	Subject device	Predicated device	Comparison
510(k) number	K203702	K163168
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The Vinyl ExaminationGloves(Yellow) is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer.	The Vinyl ExaminationGlove (White, Blue, orYellow) is a disposabledevice intended formedical purposes thatis worn on theexaminer's hands toprevent contaminationbetween patient andexaminer.	Same
Powdered or Powered free	Powdered free	Powdered free	Same
Design Feature	ambidextrous	ambidextrous	Same
Labeling Information	Single use, powder free,device color, devicename, glove size andquantity, VinylExamination Gloves,Non-Sterile	Single use, powderfree, device color,device name, glovesize and quantity, VinylExamination Gloves,Non-Sterile	Similar

Table1-General Comparison

Table2 Device Dimensions Comparison

PredicateDevice(K163168)	Designation	Size				Tolerance
	Length, mm	XS230	S230	M235	L245	XL245	min
	Width, mm	80	85	95	105	115	$\pm 5$

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	Thickness, mm:
	Finger	0.05	min
	Palm	0.08	min
Subject Device	Designation	Size				Tolerance
		S	M	L	XL
	Length, mm	240	240	240	240	±10
	Width, mm	85	95	105	115	±5
	Thickness, mm:
	Finger, mm	0.10	±0.05
	Palm, mm	0.08	min
Remark	SIMILAR

Table 3 Performance Comparison

Item	Subject device	Predicated device	Comparison
Colorant	Yellow	White, Blue, Yellow	Similar
PhysicalProperties	BeforeAgingTensileStrength	11MPa, min	15MPa, min	Similar
	UltimateElongation	300%min	380%min	Similar
	AfterAgingTensileStrength	11MPa, min	15MPa, min	Similar
	UltimateElongation	300%min	380%min	Similar
	Comply with ASTM D5250		Comply with ASTM D5250	SAME
Freedom from Holes		Be free from holes when tested in accordance with ASTM D5151 AQL=2.5	Be free from holes when tested in accordance with ASTM D5151 AQL=2.5	SAME
Powder Content		0.01 mg per glove	Meet the requirements ofASTM D6124	SIMILAR

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.

Table4 Safety Comparison

Item		Subject device	Predicated device	Comparison
Material		Vinyl	Vinyl	SAME
Biocompatibility	Irritation	Under the conditions of the study, not an irritant	Comply with ISO10993-10	SAME

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	Sensitization	Under conditions of thestudy, not a sensitizer.	Under conditions of thestudy not a sensitizer
	Cytotoxicity	Under conditions of thestudy, did not showpotential toxicity to L-929cells.	/	DIFFERENT
Label and Labeling		Meet FDA's Requirement	Meet FDA'sRequirement	SIMILAR

8.0 Non-Clinical Test Conclusion

The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTMD5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

9.0 Clinical Test Conclusion

Clinical testing is not needed for this device.

10.0_Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.

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.