The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) 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 glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device based on bench testing (non-clinical testing) rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the requested points related to AI, MRMC studies, expert ground truth adjudication, and clinical trial specifics are not applicable to this submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D5250	Physical Dimensions Test	Length (mm): S/M/L/XL: ≥230Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5Thickness (mm): Finger: ≥0.08, Palm: ≥0.08	Length (mm): >230 / PassWidth (mm): S: 83-87 / Pass; M: 92-97 / Pass; L: 104-106 / Pass; XL: 112-117 / PassThickness (mm): Finger: 0.13-0.14 / Pass; Palm: 0.09-0.11 / Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125 / Pass (This indicates 0 holes found in 125 samples tested)
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0mg	0.17~0.26mg / Pass
ASTM D412	Physical properties (Before Aging)Tensile StrengthUltimate Elongation	Before Aging:Tensile Strength: ≥11MPaUltimate Elongation: ≥300%	Before Aging:Tensile Strength: 12~~22MPa / PassUltimate Elongation: 331~~589% / Pass
ASTM D412	Physical properties (After Aging)Tensile StrengthUltimate Elongation	After Aging:Tensile Strength: ≥11MPaUltimate Elongation: ≥300%	After Aging:Tensile Strength: 11~~19MPa / PassUltimate Elongation: 325~~544% / Pass
ISO 10993-5	Cytotoxicity	In Vitro Cytotoxicity: Not cytotoxic	Under conditions of the study, device extract is not cytotoxic. / 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

Sample Size for Test Set: The document explicitly mentions "0/125 / Pass" for the ASTM D5151 Watertightness Test, indicating a sample size of 125 for this test. For other "Pass" results, the exact sample sizes are not explicitly stated, but the tests are typically performed on a statistically relevant number of samples to demonstrate compliance with the ASTM/ISO standards.
Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer. The company is Anhui Bytech Medical Supplies Co., Ltd., located in Anhui Province, China. The data is from the manufacturer's internal testing as part of their premarket notification. The document indicates these are "non-clinical tests."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a medical device 510(k) submission for examination gloves, which are low-risk devices. The "ground truth" for proving the device meets acceptance criteria comes from standardized laboratory bench testing (e.g., measuring physical properties, mechanical strength, and biocompatibility), not from expert interpretation of medical images or clinical outcomes. Therefore, no medical experts were involved in establishing "ground truth" for the performance tests.

4. Adjudication Method for the Test Set

Not Applicable. As the "ground truth" is established via objective physical and chemical measurements (bench testing) according to international standards (ASTM, ISO), there is no need for expert adjudication. The results are quantitative and directly compared to pre-defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not Applicable. This device is an examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are relevant for evaluating the impact of AI on human readers' performance in tasks like image interpretation, which is not pertinent to this device.

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

Not Applicable. There is no AI algorithm involved with this device; it is a physical product (gloves).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective, quantitative measurements from standardized laboratory tests according to recognized international consensus standards (ASTM and ISO). Examples include:
- Direct measurement of dimensions (length, width, thickness).
- Quantification of tensile strength and ultimate elongation.
- Detection of holes using a water integrity test.
- Measurement of residual powder content.
- Biological performance testing (cytotoxicity, irritation, sensitization) in vitro, which involves observing cellular responses under controlled lab conditions.

8. The Sample Size for the Training Set

Not Applicable. This submission is for a physical medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process itself involves quality control and process validation, which might involve sample testing, but this is distinct from "training data" for an algorithm.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided document.

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.

September 28, 2022

Anhui Bytech Medical Supplies Co., Ltd. % Boyle Wang Consultant Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K222442

Trade/Device Name: Disposable Vinyl Examination Gloves (Pink, Black, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: July 8, 2022 Received: August 12, 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222442

Device Name DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)

Indications for Use (Describe)

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 - K222442

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

1.0 Submitter's Information

ANHUI BYTECH MEDICAL SUPPLIES CO., LTD. Name: Address: LingBi Economic Development Zone (North), SuZhou City, Anhui Provice, China. Phone Number: +86-15212555271 Contact: Lijun Chen Date of Preparation: Jul.8, 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 (Pink, Black, Blue)
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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6.0 Device Description

7.0 Technological Characteristic Comparison Table

Item	Subject Device(K222442)	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(Pink, Black,Blue) 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	Pink, black, blue	Clear	DifferentAnalysis 1
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;	Length:S≥230;M≥235;L≥245;XL≥245;	SimilarAnalysis 2

Table1-General Comparison

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		L: 105±5;XL: 115±5	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 2
PhysicalProperties	BeforeAging	Tensile StrengthUltimate Elongation	11MPa, min300% min	Tensile StrengthUltimate Elongation	15MPa, min380% min	Similar Analysis 3
	AfterAging	Tensile StrengthUltimate Elongation	11MPa, min300%min	Tensile StrengthUltimate Elongation	15MPa, min380%min	Similar Analysis 3
		Freedom from Holes	Be free from holes when tested in accordance with ASTMD5151AQL=2.5	Be free from holes when tested in accordance with ASTMD5151AQL=1.5	Similar Analysis 4
	Powder Content	Meet the requirements of ASTM D6124	Meet the requirements of ASTM D6124	Same
Biocompatibility	ISO 10993-10;Under the conditions of the study, not an irritant or a sensitizer	Comply with ISO10993-10	Same
Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5	Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5	Same

Analysis 1:

The subject device (pink, black, blue) has different color to the predicate device (clear), but all proposed devices are conducted the biocompatibility test.

Analysis 2:

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

Analysis 3:

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

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Analysis 4:

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

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.

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: 83-87 / PassM: 92-97/ PassL: 104-106/ PassXL: 112-117/ PassThickness (mm):Finger:0.13-0.14/ PassPalm:0.09-0.11/Pass
ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTMD5151 AQL 2.5	0/125 / Pass

Table 2 - Summary of non-clinical performance testing

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ASTMD6124	PowderContent	Meet the requirements of ASTMD6124 < 2.0mg			0.17~0.26mg / Pass
ASTMD412	Physicalproperties	BeforeAging	TensileStrength	≥11MPa	12~22MPa / Pass
			UltimateElongation	≥300%	331~589% / Pass
		AfterAging	TensileStrength	≥11MPa	11~19MPa / Pass
			UltimateElongation	≥300%	325~544% / Pass
ISO10993-5	Cytotoxicity	In Vitro Cytotoxicity			Under conditions ofthe study, deviceextract is notcytotoxic. / 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(Pink, Black, Blue) 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.