The Disposable Nitrile Medical Powder-free Glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Disposable Nitrile Medical Powder-free Glove. It does not describe an AI/ML-driven medical device. Therefore, the request to describe acceptance criteria and a study proving an AI/ML device meets those criteria cannot be fully answered from this document.

However, I can extract information related to the non-clinical performance testing conducted for this medical device (the glove), which serves a similar purpose to acceptance criteria and study results for verifying performance against established benchmarks.

Here's an adaptation of the requested format focusing on the non-clinical performance of the medical glove, as an AI/ML study was not conducted:

Device: Disposable Nitrile Medical Powder-free Glove (non-AI/ML device)

This document does not pertain to an AI/ML medical device. Therefore, information regarding "Multi-Reader Multi-Case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "effect size of human readers improving with AI," "sample size for training set," and "how ground truth for training set was established" is not applicable.

The following tables and information describe the acceptance criteria and the non-clinical testing proving the device meets these criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length (mm): S: ≥220; M/L/XL: ≥230Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10Thickness (mm): Finger: ≥0.05; Palm: ≥0.05	Length (mm): > 230/PassWidth (mm): S: 83-86 /Pass; M: 94-98/ Pass; L: 101-103/ Pass; XL:113-115/ PassThickness (mm): Finger: 0.13-0.15/Pass; Palm: 0.09/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125/Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 << 2.0mg	0.21-0.24mg/Pass
ASTM D412	Physical Properties	Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400%	Before Aging: 14.3-20.7MPa/Pass; 500-699%/PassAfter Aging: 14.0-17.8MPa/Pass; 490-569%/Pass
ISO 10993-11	Cytotoxicity (Systemic Toxicity)	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo / 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 does not explicitly state the sample size for each test, but it provides specific values for some tests:

Watertightness Test (ASTM D5151): Tested 125 units (0/125/Pass implies a sample size of 125).
For other tests like dimensions, powder content, and physical properties, specific sample sizes are not detailed but are assumed to be in compliance with the respective ASTM and ISO standards.
Data Provenance: Not specified, but generally, these non-clinical tests are conducted by the manufacturer or a contracted lab in the country of origin (China, in this case). The data is retrospective in the sense that it's gathered specifically for the submission.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This is a physical medical device (glove), not an AI/ML device requiring expert interpretation for ground truth. Ground truth is established through standardized physical, chemical, and biological testing methods.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML device involving human interpretation, no adjudication method is relevant. Test results are objective measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool.

6. Standalone Performance (Algorithm Only)

Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

Objective Measurement against Industry Standards: The ground truth for this device's performance is established by standardized test methods from organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards define the physical, chemical, and biological properties expected of such a device. For example, "Tensile Strength ≥14MPa" is an objective ground truth defined by ASTM D412.

8. The Sample Size for the Training Set

Not Applicable. 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

Not Applicable. This is a physical medical 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). 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.

January 3, 2022

Fujian Chunhui Medical Supply 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: K213187

Trade/Device Name: Disposable Nitrile Medical Powder-free Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 18, 2021 Received: September 29, 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 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) K213187

Device Name Disposable Nitrile Medical Powder-free Glove

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 K213187

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

1.0 Submitter's Information

Name: Fujian Chunhui Medical Supply Co., Ltd. Address: No.179, Shanggeteng Ping, Shifang Village, Shifang County, Wuping Town, Longyan City, Fujian Province, China. Phone Number: +86-18060003170 Contact: Han Cai Date of Preparation: Sept 18, 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: Disposable Nitrile Medical Powder-free Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S. M. L. XL

3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593

5.0 Indication for Use

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6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. 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	Predicated Device(K203593)	Comparison
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The Disposable NitrileMedical Powder-free Gloveis intended to be worn onthe hands of examiners toprevent contaminationbetween patient andexaminer. This is asingle-use, powder-free,non-sterile device.	The nitrile examinationglove is intended to beworn on the hands ofexaminers toprevent contaminationbetween patient andexaminer. This is asingle-use, powder-free,non-sterile device.	Same
Material	Nitrile	Nitrile	Same
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Colorant	Blue	Blue	Same
LabelingInformation	Single-use indication,powder free, device color,device name, glove size andquantity, Non-Sterile	Single-use indication,powder free, device color,device name, glove sizeand quantity, Non-Sterile	Same
Dimensions(mm)	Length:S:≥220;M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;XL: 120±10	Length:S:≥220;M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;XL: 120±10	Same

Table1-General Comparison

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	Thickness(mm)	Finger: ≥0.05;Palm: ≥0.05	Finger: ≥0.05;Palm: ≥0.05	Same
PhysicalProperties	BeforeAging	TensileStrength	14MPa, min	TensileStrength	14MPa, min	Same
		UltimateElongation	500% min	UltimateElongation	500% min	Same
	AfterAging	TensileStrength	14MPa, min	TensileStrength	14MPa, min	Same
		UltimateElongation	400%min	UltimateElongation	400%min	Same
	Freedom fromHoles	Be free from holes whentested in accordance withASTMD5151 AQL=2.5		Be free from holes whentested in accordance withASTMD5151 AQL=2.5		Same
	Powder Content	Meet the requirements ofASTM D6124		Meet the requirements ofASTM D6124		Same
	Biocompatibility	ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer		ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer		Same
		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.ISO 10993-5Under conditions of thestudy, device extract is		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.ISO 10993-5Under conditions of thestudy, device extract is		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:

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.

ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for

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systemic toxicity.

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 D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

TestMethod	Purpose	Acceptance Criteria	Results
ASTMD6319	PhysicalDimensionsTest	Length(mm):S:≥220;M/L/XL:≥230;Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10Thickness (mm):Finger: ≥0.05Palm: ≥0.05	Length(mm):> 230/Pass;Width(mm):S: 83-86 /PassM: 94-98/ PassL: 101-103/ PassXL:113-115/ PassThickness (mm):Finger: 0.13-0.15/PassPalm: 0.09/Pass
ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/125/Pass
ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 <2.0mg	0.21-0.24mg/Pass;
ASTMD412	Physicalproperties	Before AgingTensile Strength ≥14MPaUltimate Elongation ≥500%After AgingTensile Strength ≥14MPaUltimate Elongation ≥400%	14.3-20.7MPa/Pass;500-699%/Pass;14.0-17.8MPa/Pass;490-569%/Pass;
ISO10993-11	Cytotoxicity	Non- acute systemictoxicity	Under conditions ofthe study, did notshow acute systemic
			toxicity in vivo / 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

Table 2 - Summary of non-clinical performance testing

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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 Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device K203593.

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.