The Vinyl Glove is 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 clear. 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 text is a 510(k) Summary for a Vinyl Glove, which is a Class I medical device. This type of device does not typically involve complex algorithms or AI; instead, its performance is assessed against established physical and biocompatibility standards for medical gloves.

Therefore, the requested information regarding AI/algorithm performance, multi-reader multi-case studies, expert consensus for ground truth, and training set details are not applicable to this device submission. The "study" here refers to the non-clinical testing performed to demonstrate compliance with relevant standards.

Here's an analysis of the provided text in the context of the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

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

Test Method (Reference Standard)	Purpose	Acceptance Criteria	Reported Device Performance (Results)
ISO 10993-10:2010	To determine if device is a skin irritant	The device must be a non-irritant	Pass (Under the conditions of the study, not an irritant)
ISO 10993-10:2010	To determine if device is a skin sensitizer	The device must be a non-sensitizer	Pass (Under conditions of the study, not a sensitizer)
ISO 10993-5:2009	To determine if the device is potential toxicity to L-929 cells	The device must be a non-toxicity.	Pass (Under conditions of the study, did not show potential toxicity to L-929 cells)
ASTM D6124-06 (Reapproved 2017)	To determine residual powder	≤ 2 mg/glove	Pass (Indicates it met the criterion; specific value not provided in the summary)
ASTM D5151-19	To determine water tightness	Meet the requirements of ASTM D5151 AQL 2.5	Pass (0/125 leaks)
ASTM D5250-19	To determine physical dimensions	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(mm): >230 (for all sizes S, M, L, XL). Width(mm): S: 84-86; M: 95-97; L: 105-107; XL: 115-117. Thickness (mm): Finger: 0.09-0.11; Palm: 0.08-0.11 (Note: These ranges appear to be for all sizes or representative of the range across sizes). All reported dimensions fall within the specified tolerances. Pass.
ASTM D412-06a-2013	To determine 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: 15.1~17.4 MPa; Ultimate Elongation: 552%~~560%. After Aging: Tensile Strength: 15.7~~17.4 MPa; Ultimate Elongation: 527%~550%. All reported values for both before and after aging exceed the acceptance criteria. Pass.

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

Sample Size for Test Set:
- For "Freedom from Holes" (ASTM D5151-19): The test result states "0/125 leaks," implying a sample size of 125 gloves for this test.
- For other tests (Biocompatibility, Residual Powder, Physical Dimensions, and Physical Properties), specific sample sizes are not explicitly stated in this summary but are implied to be sufficient to establish compliance with the listed ASTM/ISO standards. These standards often specify minimum sample sizes for specific tests.
Data Provenance: The document does not explicitly state the country of origin for the testing data. Given the manufacturer's location (Jiangsu, China) and the correspondent's location (Shanghai, China), it is highly probable that the testing was conducted in China.
Retrospective or Prospective: This evaluation involves non-clinical laboratory testing of manufactured product samples. It is inherently prospective in the sense that the tests are performed on the device samples specifically for the purpose of demonstrating compliance for the submission.

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

This is not applicable for this type of device (Vinyl Glove). "Ground truth" in the context of diagnostic AI/algorithms typically involves expert interpretation of medical images or clinical data. For a physical medical device like a glove, "ground truth" is established by adherence to globally recognized and validated laboratory testing standards (ASTM, ISO), using calibrated equipment and defined methodologies, rather than human expert interpretation of an outcome. The "experts" are the qualified laboratory technicians and scientists performing the tests according to the standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/algorithm studies where human readers are interpreting imaging or clinical data and their interpretations need to be reconciled to form a consensus "ground truth." For laboratory testing of a physical product, the test results are objective measurements or categorical outcomes (e.g., pass/fail for irritation), not subjective interpretations requiring adjudication.

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 is not applicable. MRMC studies are conducted for diagnostic AI/imaging devices to assess how the AI assists human readers in making diagnoses. The Vinyl Glove is a Class I physical barrier device, not a diagnostic device with an AI component.

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

This is not applicable. There is no algorithm or AI component in this device. Performance is tied to the physical and biocompatible properties of the glove material and manufacturing.

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

The "ground truth" for this device's performance is based on well-established international consensus standards and validated test methods (ASTM and ISO standards). These standards define the acceptable physical properties (e.g., tensile strength, dimensions, freedom from holes) and biological safety (biocompatibility) criteria for medical gloves. Compliance is determined by objective laboratory measurements and tests as defined by these standards.

8. The sample size for the training set

This is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

This is not applicable, as there is no training set for this 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.

September 17, 2021

Jiangsu Dihong Industry and Trade Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K211904

Trade/Device Name: Vinyl Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 19, 2021 Received: June 21, 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.

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542 of the Act); 21 CFR 1000-1050.

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-

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.

Liqun Zhao -S

For 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) K211904

Device Name Vinyl Glove

Indications for Use (Describe)

The Vinyl Glove is 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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510(k) Summary- K211904

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

1.0 Submitter's Information

Jiangsu Dihong Industry and Trade Co.,Ltd. Name: Address: Donqxiaodian Industrial Park, Shuyang City, Jiangsu, China Phone Number: +86-18761104047 Contact: Sue Chen Date of Preparation: 09/09/2021

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 Glove 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 Vinyl Patient Examination Gloves (White, Blue, Yellow) Device: 510(k) number: K163168

5.0 Indication for Use

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The Vinyl Glove is 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 Characteristic Comparison Table

Item	Subject device	Predicate device	Comparison
510(k) number	K211904	K163168	-
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The Vinyl Glove is 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 Glove, 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	XS	S	M	L	XL
		230	230	235	245	245	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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(K211904)		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,so the differences do not raise any new safety or performance questions.

Item	Subject device(K211904)	Predicate device(K163168)	Comparison
Colorant	Clear	White, Blue, Yellow	Analysis 1
PhysicalProperties	Before AgingTensile Strength	11MPa, min	15MPa, min	Analysis 2
	Ultimate Elongation	300%min	380%min	Analysis 2
	After AgingTensile Strength	11MPa, min	15MPa, min	Analysis 2
	Ultimate Elongation	300%min	380%min	Analysis 2
Comply with ASTM D5250	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	< 0.04 mg per glove, Meet the requirements of ASTM D6124	Meet the requirements of ASTM D6124	Similar

Table3 Performance Comparison

Analysis 1: The colorant of the subject device is different with that of the predicate device, the subject device was evaluated according to ISO 10993-1 standards, and there were no risks identified.

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

Table: Safety Comparison
Item	Subject device	Predicated device	Comparison

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Material		Vinyl	Vinyl	Same
Biocompatibility	Irritation	Comply withISO10993-10.Under the conditionsof the study, not anirritant		Same
	Sensitization	Comply withISO10993-10.Under conditions ofthe study, not asensitizer.	Comply withISO10993-10
	Cytotoxicity	Comply withISO10993-10.Under conditions ofthe study, did notshow potentialtoxicity to L-929 cells.	Not provided	Different
Label and Labeling		Meet FDA'sRequirement	Meet FDA'sRequirement	Same

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 as shown in Table 5 Biocompatibility and Table 6 Non-Clinical Testing below:

Test Method	Purpose	Acceptance Criteria	Results
ISO 10993-10:2010Tests For Irritation AndSkin Sensitization	To determine if deviceis a skin irritant	The device must be anon-irritant	Pass
ISO 10993-10:2010Tests For Irritation AndSkin Sensitization	To determine if deviceis a skin sensitizer	The device must be anon- sensitizer	Pass
ISO 10993-5:2009Tests For In VitroCytotoxicity	To determine if thedevice is potentialtoxicity to L-929cells.	The device must be anon toxicity.	Pass

Table 5 Biocompatibility Testing

Table 6 Non-Clinical Testing

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6124-06(Reapproved 2017)Standard Test Method	To determine residualpowder	≤ 2 mg/glove	Pass

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for Residual Powder onMedical Gloves
ASTMD5151-19Standard Test Methodfor Detection of Holesin Medical Gloves	To determine watertightness	Meet the requirementsof ASTM D5151 AQL2.5	0/125 leaksPass
ASTM D5250-19Standard Specificationfor Poly (vinyl chloride)Gloves for MedicalApplication	To determine physicaldimensions	Length(mm):≥230.	Length(mm):>230
		Width(mm):	Width(mm):
		S: 85±5;	S: 84-86
		M: 95±5;	M: 95-97
		L: 105±5;	L: 105-107
		XL: 115±5;	XL: 115-117
			Pass
ASTM D412-06a-2013Standard Test Methodsfor Vulcanized Rubberand ThermoplasticElastomers—Tension	To determine physicalproperties	Thickness (mm):	Finger: 0.09-0.11
		Finger: ≥0.08	Palm: 0.08-0.11
		Palm: ≥0.08	Pass
		Before Aging:	Before Aging:
		TensileStrength≥11MPa	Tensile Strength:15.1~17.4 MPa
		UltimateElongation≥300%	Ultimate Elongation:552%~560%
		After Aging:	After Aging:
		TensileStrength≥11MPa	Tensile Strength:15.7~17.4 MPa
		UltimateElongation≥300%	Ultimate Elongation:527%~550%
			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 in 510(k) submission K211904, Vinyl Glove, 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.