The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are 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 non-sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for Vinyl Examination Gloves, a Class I medical device. This type of device does not involve AI or complex software, and thus the request asking about AI/algorithm performance metrics is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing, not through AI/algorithm performance.

Therefore, many of the requested points regarding AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for AI models, cannot be extracted from this document as they are not relevant to the device being described.

However, I can extract the acceptance criteria and performance data for the physical properties of the gloves, as well as the non-clinical testing information:

Description of Acceptance Criteria and Study Proving Device Meets Criteria (for Vinyl Examination Gloves)

This document describes the non-clinical testing performed to demonstrate that the Vinyl Examination Gloves (Yellow) are substantially equivalent to a legally marketed predicate device (K163168). The acceptance criteria are based on recognized standards for medical gloves, primarily ASTM D5250, ASTM D5151, and ASTM D6124, as well as biocompatibility standards ISO 10993-5 and ISO 10993-10.

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria (from Standard)	Reported Device Performance (Results)
ASTM D5250	Physical Dimensions Test	Length(mm): ≥230;Width(mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5;Thickness (mm): Finger: ≥0.08, Palm: ≥0.08	Length: > 230 / PassWidth: S: 84-85/Pass; M: 94-96/Pass; L: 104-106/Pass; XL: 113-115/PassFinger Thickness: 0.12~0.13/PassPalm Thickness: 0.08/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125 leaks / Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0mg	0.19 mg/Pass
ASTM D412	Physical Properties (Tensile Strength & Ultimate Elongation)	Before Aging: Tensile Strength ≥11MPa; Ultimate Elongation ≥300%After Aging: Tensile Strength ≥11MPa; Ultimate Elongation ≥300%	Before Aging: Tensile Strength: 13-18/Pass; Ultimate Elongation: 300-340/PassAfter Aging: Tensile Strength: 14-18/Pass; Ultimate Elongation: 300-320/Pass
ISO 10993-5	Cytotoxicity	Non-cytotoxic	Under conditions of the study, did not show potential toxicity to L-929 cells./ 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

2. Sample Size Used for the Test Set and Data Provenance

The document indicates sample sizes for specific tests:

Watertightness Test for Detection of Holes (ASTM D5151): Out of 125 units tested, 0 leaks were detected, meeting the AQL 2.5 requirement.
Powder Content (ASTM D6124): A "Medium glove" was used as the representative sample.
Physical properties (ASTM D412): A "Medium glove" was used as the representative sample.
The exact sample sizes for other physical dimensions and biocompatibility tests are not explicitly stated in the summary, but they are implied to be sufficient to meet the respective standard requirements.

Data Provenance: The tests were conducted by the manufacturer, LIUPING TRADING CO.,LTD., in Shandong, China. The data is from non-clinical testing performed retrospectively for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This product is a physical medical device (gloves), not an AI/algorithm. Ground truth is established through standardized laboratory testing methods, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or AI model output, where there might be disagreements on classifications (e.g., in medical image analysis). For physical product testing, the results are objectively measured against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not Applicable. MRMC studies are relevant for evaluating the performance of AI-assisted systems in clinical decision-making contexts (e.g., radiology). This is a physical product.

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

Not Applicable. This is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the specifications and test methods defined by recognized industry standards, specifically:

ASTM D5250 for physical dimensions and properties.
ASTM D5151 for watertightness (freedom from holes).
ASTM D6124 for residual powder content.
ISO 10993-5 for in vitro cytotoxicity.
ISO 10993-10 for irritation and skin sensitization.

These standards define the objective measurements and pass/fail criteria.

8. The Sample Size for the Training Set

Not Applicable. This is a physical product, not an AI/algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As stated above, this is a physical product and does not have a "training set" in the context of AI.

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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

October 24, 2021

Liuping Trading CO.,LTD. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai. 200120 China

Re: K211698

Trade/Device Name: Vinyl Examination Gloves(Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 17, 2021 Received: September 23, 2021

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 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 Clarence W. Murray III, 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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Indications for Use

510(k) Number (if known) K211698

Device Name Vinyl Examination Gloves(Yellow)

Indications for Use (Describe)

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

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

(K211698)

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

1.0 Submitter's Information

Name: LIUPING TRADING CO.,LTD. Address: Xingtong Town, Linyi County, Dezhou City 251500, Shandong, China. Phone Number: Contact: Jing Li Date of Preparation: 09/17/2021

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: 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: Hebei Hongtai Plastic Products Company Limited Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 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 Technological Characteristics Comparison Table With The Predicate Device

Item	Subject device	Predicate device	Comparison
510(k) number	K211698	K163168	/
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	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.	The Vinyl Examination Glove (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.	Same
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
LabelingInformation	Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile	Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination 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	$\pm 5$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Subject Device	Designation	Size					Tolerance

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(K211698)		S	M	L	XL
	Length, mm	230	230	230	230	min
	Width, mm	85	95	105	115	±5
	Thickness, mm:
	Finger	0.08				min
	Palm	0.08				min
Remark	Similar

Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250-19.

Item		Subject deviceK211698	Predicate deviceK163168	Comparison
Colorant		Yellow	White, Blue, Yellow	Same
PhysicalProperties	BeforeAging	TensileStrength11MPa, min	15MPa, min	Different
		UltimateElongation300%min	380%min	Different
	AfterAging	TensileStrength11MPa, min	15MPa, min	Different
		UltimateElongation300%min	380%min	Different
	Comply with ASTM D5250		Comply with ASTM D5250	Same
Freedom from Holes			Be free from holeswhen tested inaccordance withASTM D5151AQL=2.5	Be free from holeswhen tested inaccordance withASTM D5151AQL=2.5	Same
Powder Content		Meet therequirements ofASTM D6124 <2mg per glove.	Meet therequirements ofASTM D6124	Similar

Table3 Performance Comparison

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

Item	Subject deviceK211698	Predicated deviceK163168	Comparison
Material	Vinyl	Vinyl	Same
Biocompatibility	Irritation	Under theconditions of thestudy, not an irritant	Comply withISO10993-10	Same
	Sensitization	Under conditions of

Table4 Safety Comparison

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		the study, not asensitizer.
	Cytotoxicity	Under conditions of /the study, did notshow potentialtoxicity to L-929cells.		Similar
Label and Labeling		Meet FDA'sRequirement	Meet FDA'sRequirement	Same

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 10993-10:2010 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

ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

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

TestMethodology	Purpose	Acceptance Criteria	Results
ASTM D5250	PhysicalDimensionsTest	Length(mm):≥230;	Length:> 230/ Pass
		Width(mm):S: 85±5;M: 95±5;L: 105±5;XL: 115±5;Thickness (mm):Finger: ≥0.08Palm: ≥0.08	Width:S: 84-85/PassM: 94-96/PassL: 104-106/PassXL: 113-115/PassFinger: 0.12~0.13/PassPalm: 0.08/Pass
ASTM D5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/125 leaks / Pass

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ASTM D6124	PowderContent(Medium gloveis therepresentativesample of theproduct)	Meet the requirements of ASTM D6124< 2.0mg	0.19 mg/Pass;
ASTM D412	Physicalproperties(Medium gloveis therepresentativesample of theproduct)	BeforeAging	TensileStrength	≥11MPa	13-18/Pass
			UltimateElongation	≥300%	300-340/Pass
		After Aging	TensileStrength	≥11MPa	14-18/Pass
			UltimateElongation	≥300%	300-320/Pass
		ISO 10993-5	Cytotoxicity	Non-cytotoxic	Under conditions of thestudy, did not show potentialtoxicity to L-929 cells./ Pass
		ISO 10993-10	Irritation	Non-irritating	Under the conditions of thestudy, not an irritant/ Pass
		ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of thestudy, 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 proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K163168.

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.