Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

The Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves. This type of medical device falls under Class I, reserved, and is a non-AI/ML device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML device performance (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) are not applicable in this context.

The document focuses on demonstrating substantial equivalence to a predicate device (K222498) through a series of bench tests and biocompatibility tests, primarily based on established ASTM and ISO standards for medical gloves.

Here's how the information provided relates to the closest equivalent of "acceptance criteria" and "proof" for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are the performance requirements set forth by relevant industry standards (ASTM, ISO). The "reported device performance" is the result of the bench tests demonstrating compliance with these standards.

Acceptance Criterion (Standard)	Reported Device Performance
Physical Dimensions (ASTM D6319-19 Table 2): Conformity to specified length, width, and thickness ranges.	The subject device complies with the dimension requirements prescribed in ASTM D6319-19.
Physical Property Characteristics (ASTM D6319-19 Table 3, before and after accelerated aging): Minimum Tensile Strength and Ultimate Elongation.	Before and after accelerated aging, the subject device complies with the physical requirements specified in ASTM D6319-19 Table 3.
Freedom From Holes (ASTM D5151-06): No water leakage.	No water leakage is inspected. The subject device complies with the requirements specified in ASTM D5151.
Residual Powder (ASTM D6124-06, R2017): Less than 2 mg per glove.	Residual Powder less than 2 mg per glove. The subject device complies with the requirements specified in ASTM D6124.
Acute Systemic Toxicity (ISO 10993-11): No evidence of systemic toxicity from the extract.	The test article has no potential acute system toxicity on ICR mice in the extraction method.
Skin Irritation (ISO 10993-23: 2021): No skin irritation.	Under the experimental conditions, the test article has no skin irritation on rabbits.
Skin Sensitization (ISO 10993-10: 2021): No evidence of delayed dermal contact sensitization.	The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

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

Sample Size: Not explicitly stated as a single number (e.g., N=X gloves). The testing is generally done on samples taken from production lots to ensure consistency. The specific sample sizes for each test are typically defined within the respective ASTM/ISO standards (e.g., AQL for freedom from holes).
Data Provenance: The device manufacturer is Hebei Titans Hongsen Medical Technology Co., Ltd. in China. The tests were performed to demonstrate compliance with international standards (ASTM, ISO). The data is generated through prospective bench testing and biological evaluation in a controlled laboratory environment.

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

Not Applicable: For this Class I device, the "ground truth" is defined by the objective, quantifiable parameters and pass/fail criteria established in the ASTM and ISO standards for glove performance and biocompatibility. There is no need for human expert consensus on subjective interpretations, as would be the case for image-based diagnostic AI. The tests are conducted by trained technicians in accredited labs according to standardized protocols.

4. Adjudication Method for the Test Set

Not Applicable: As the "ground truth" is based on objective measurements and predefined standard thresholds, there is no need for an adjudication method by multiple human readers. Test results are either within the acceptable range or not.

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

No: MRMC studies are relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This is a non-AI/ML medical glove, so such a study is not applicable.

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

Yes (in concept, but not an "algorithm"): The "standalone performance" for this device refers to its ability to meet the physical and biological requirements of the standards independently, without human interaction during "use" in a diagnostic or interpretive sense. The bench tests and biocompatibility tests effectively demonstrate this "standalone" performance against defined metrics.

7. The Type of Ground Truth Used

Standard-based Physical and Chemical Properties / Biological Reactions: The ground truth is established by the specified acceptance criteria within the referenced ASTM (e.g., D6319-19 for physical properties, D5151-06 for holes, D6124-06 for residual powder) and ISO standards (e.g., ISO 10993-10 for sensitization, 10993-11 for systemic toxicity, 10993-23 for irritation) for medical examination gloves. These are objective, measurable physical properties and biological responses.

8. The Sample Size for the Training Set

Not Applicable: This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

Not Applicable: No training set exists for this type of device.

In summary, for medical gloves, the regulatory acceptance and "proof" of performance revolve around rigorous non-clinical bench testing and biocompatibility assessments against established international standards, rather than clinical studies or AI/ML specific performance metrics.

Summary

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March 23, 2023

Hebei Titans Hongsen Medical Technology Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. Rm. 912 Building #15. XiYueHui. No.5. YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K223895

Trade/Device Name: Disposable Medical Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 28, 2022 Received: December 28, 2022

Dear Ray 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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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 531-542 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.

Bifeng Qian -S

Bifeng Qian, M.D., 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223895

Device Name

Disposable Medical Nitrile Examination Gloves

Indications for Use (Describe)

Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand 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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K223895 510(k) Summary

1. Date of Preparation: 2023/03/22
1. Submitter

Hebei Titans Hongsen Medical Technology Co., Ltd.

Eastern Industrial Zone, Nangong City, Xingtai City, 051800, Hebei, China Contact Person: Xiaojing Zhao Position: Office clerk Tel: +86-13383292209 Email: sara@titans-cn.com

1. Submission Correspondent

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

1. Subject Device Identification
  510(k) Number: K223895

Trade Name: Disposable Medical Nitrile Examination Gloves

Common Name: Polymer Patient Examination Glove

Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

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న్. Predicate Device Identification
510(k) Number: K222498

Product Name: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

Manufacturer: Humanwell Healthcare Group Medical Supplies Co., Ltd

Regulatory Information:

Classification: I

Product Code: LZA

Regulation Number: 21 CFR 880.6250

Review Panel: General Hospital

Common Name: Polymer Patient Examination Glove

1. Device Description
  The Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free.

The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.

Indication For Use Statement 7.
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Technological Characteristic Comparison Summary 8.

ITEM	Proposed Device (K223895)Disposable Medical Nitrile ExaminationGloves	Predicate Device (K222498)Medical Examination Gloves (Nitrile) (XS,S, M, L, XL)	Remark
Product Code	LZA	LZA	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	SAME
Intended Use	Disposable Medical Nitrile ExaminationGloves are disposable device intended formedical purpose that is worn on theexaminer's hand to prevent contaminationbetween patient and examiner.	The Medical Examination Glove (Nitrile) isa disposable device intended for medicalpurposes that is worn on the examiner'shand to prevent contamination betweenpatient and examiner.	SAME
Powder free	Yes	Yes	SAME

Table 1 General Comparison

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Design feature	Ambidextrous	Ambidextrous	SAME
Material	Nitrile	Nitrile	SAME
OTC use	Yes	Yes	SAME
Sterility	Non-sterile	Non-sterile	SAME
Use	Single use	Single use	SAME
Label	Single-use, indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free orange, Non-Sterile	Single-use, indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Blue, Non-Sterile	SAME

Table 2 Device Dimensions Comparison

Proposed Device (K223895)Disposable Medical NitrileExamination Gloves	Designation	Size					Tolerance
	Length, mm	XS230	S230	M230	L230	XL230	min
	Width, mm	70	80	95	110	120	$\pm$ 10
	Thickness, mm:
	Finger	0.1					$\pm$ 0.03
	Palm	0.08					$\pm$ 0.03
	Cuff	0.07					$\pm$ 0.03
Predicate Device (K222498)Medical Examination Gloves(Nitrile) (XS, S, M, L, XL)	Designation	Size					Tolerance
	Length, mm	XS220	S220	M230	L230	XL230	min
	Width, mm	70	80	95	110	120	$\pm$ 10
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
	Cuff	unavailable					min
Remark	Similar

Analysis:

The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319. So the difference does not affect the substantial equivalence in effectiveness and safety.

ITEM	Proposed Device (K223895)Disposable Medical Nitrile Examination Gloves	Predicate Device (K222498)Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)	Remark
Colorant	Orange	Blue	Different
PhysicalProperties	Before AgingTensile Strength	14 MPa, min	14 MPa, min	SAME
	Ultimate Elongation	500 % min	500 % min	SAME
	After AgingTensile Strength	14 MPa, min	14 MPa, min	SAME
	Ultimate Elongation	400 % min	400 % min	SAME
Freedom from Holes		Comply with ASTM D6319Be free from holes when testedin accordance with ASTMD5151G-1, AQL 1.5	Comply with ASTM D6319Be free from holes when testedin accordance with ASTMD5151G-1, AQL 1.5	SAME
Residual Powder		Meet therequirements ofASTM D6124	Meet therequirements ofASTM D6124	SAME

Table 3 Performance Comparison

Analysis:

The subject device has different colour to the predicate device. The colour of the proposed device is orange and predicate device is Blue. But the Biocompatibility testing was successfully completed for the subject device, demonstrating that the difference does not affect the substantial equivalence in effectiveness and safety.

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ITEM	Proposed Device (K223895)Disposable Medical NitrileExamination Gloves	Predicate Device (K222498)Medical Examination Gloves(Nitrile) (XS, S, M, L, XL)	Remark
Material	Nitrile	Nitrile	SAME
Biocompatibility	IrritationUnder the conditions of thestudy, not an irritant	Under the conditions of thestudy, not an irritant	SAME
	SensitizationUnder conditions of thestudy, not a sensitizer.	Under conditions of thestudy, not a sensitizer.	SAME
	acutesystemictoxicityUnder the conditions of thestudy, there was no evidenceof systemic toxicity from theextract.	Under the conditions of thestudy, there was no evidenceof systemic toxicity from theextract.	SAME
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	SAME

Analysis:

We have conducted the testing according to the ISO10993-1, Acute Systemic Toxicity, irritation and sensitization. The test results shown that no biocompatibility risk would be raised. So, we consider that the proposed device has same biocompatibility performance with the predicate device.

Summary of Non-Clinical Testing 9.

Bench tests were conducted to demonstrate that the proposed device complies with the following standards:

ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.

ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6124-06 (R2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves

Title of the test	Purpose of the test	Acceptance criteria andthe source of references	Results
PhysicalDimensions	Detection of the conformitythat whether the gloveswhether the dimensionrequirements prescribed inASTM 6319-19 Table 2.	ASTM D6319-19Standard Specification forNitrile ExaminationGloves.	The subject device complieswith the dimensionrequirements prescribed inASTM D6319-19.
PhysicalPropertyCharacteristics	Detection of the conformity thatwhether the gloves meet therequirements specified in ASTMD6319-19 Table 3, before andafter accelerated aging.	ASTM D412 Standard TestMethods for VulcanizedRubber and ThermoplasticElastomers-Tension	Before and afteraccelerated aging, thesubject device complieswith the physicalrequirements specified inASTM D6319-19 Table3.
Freedom FromHoles	Detection of holes that allowwater leakage under theconditions of the test.	ASTM D5151-06,Standard Test Method forDetection of Holes inMedical Gloves.	No water leakage isinspected.The subject devicecomplies with therequirements specified inASTM D5151.
Residual	Determine the amount of	Residual Powder less	Residual Powder less than

Table 5 Bench Tests Summary

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Powder	residual powder found on asample of medical gloves.	than 2 mg per glove asrequired in ASTM D6124-06, R2017,Standard Test Method forResidual Powder onMedical Gloves.	2 mg per glove.The subject devicecomplies with therequirements specified inASTM D6124.
AcuteSystemicToxicity	The test was designed toevaluate the potential acutesystem toxicity caused by testarticle contact with the ICRmice and extrapolating theresults to humans.	ISO 10993-11 Biologicalevaluation of medicaldevices - Part 11: Testsfor systemic toxicity.	The test article has nopotential acute systemtoxicity on ICR mice inthe extraction method.
Skin Irritation	To evaluate the potential skinirritation caused by test articlecontact with the skin surfaceof rabbits and extrapolatingthe results to humans, but itdoes not establish the actualrisk of irritation.	ISO 10993-23: 2021Biological evaluation ofmedical devices - Part 23:Tests for irritation.	Under the experimentalconditions, the test articlehas no skin irritation onrabbits.
SkinSensitization	The test was designed toevaluate the potential of a testarticle to cause skinsensitization. The test is usedas a procedure for screeningof contact allergens in guineapigs and extrapolating theresults to humans, but it doesnot establish the actual risk ofsensitization	ISO 10993-10: 2021Biological Evaluation OfMedical Devices - Part10: Tests For SkinSensitization.	The test article showedno evidence of causingdelayed dermal contactsensitization in theguinea pig.

10. Summary of Clinical Testing

Not applicable

11. Conclusions

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Medical Examination Gloves (Nitrile) (XS, S, M, L, XL), cleared under K222498.

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.