The Examination gloves-Type C (Nitrile gloves) 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.

Device Description

The proposed device is one kind of patient examination glove made from nitrile rubber compounds. The typical characters of these examination gloves are blue color, single-layer, powder-free, non-sterilized, single-use, variable size (see table 2.). These examination gloves can be worn on the examiner's hands or fingers during a medical examination. In addition, it is for over-the-counter use and also for adult use only.

AI/ML Overview

This document summarizes the acceptance criteria and performance data for Examination gloves - Type C (Nitrile gloves), as presented in the provided FDA 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance

Standard / Test	Test Description	Acceptance Criteria	Reported Device Performance
ASTM D5151-19	Freedom from holes	No water leakage (0 pinhole)	0 pinhole found
ASTM D6319-19	Physical Dimension	Multi acceptance criteria refer to ASTM D6319 Clause 7.4- TABLE 2.	Meet requirements. (Specific values in Table 4)
ASTM D6319-19	Tensile strength and Elongation	Multi acceptance criteria refer to ASTM D6319 Clause 7.5- TABLE 3.	Meet requirements. (Specific values in Table 5)
ASTM D6124-06 (Reapproved 2017)	Residual powder	$\leq$2.0 mg/glove	0.10 mg/glove (before aging), 0.12 mg/glove (after aging)
ISO 10993-10:2010	Skin sensitization and irritation	No irritation and skin sensitization	No irritation and skin sensitization
ISO 10993-11:2017	Systemic toxicity	No acute systemic toxicity	No acute systemic toxicity

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

The document does not explicitly state the specific sample sizes for each test within the "Non-Clinical Testing" section. However, the tests are conducted in conformance with recognized international and national standards (ASTM, ISO), which typically specify appropriate sample sizes and methodologies.

The provenance of the data is not explicitly stated in terms of country of origin, but it is derived from non-clinical laboratory testing performed by the manufacturer, Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., located in Nanchang City, Jiangxi Province, China. The data is retrospective, as it represents results from tests already performed on the finished device to demonstrate compliance.

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

This information is not applicable. The device in question is a physical medical device (examination gloves), and the "ground truth" for its performance is established through objective, standardized laboratory tests (e.g., water leakage for pinholes, mechanical strength tests, chemical analysis for residual powder, and biological safety assessments). These are not typically assessed by human experts establishing a "ground truth" in the way, for example, a radiologist would for an AI image analysis system.

4. Adjudication Method for the Test Set

This information is not applicable. The tests performed are objective, quantitative measurements or qualitative observations (e.g., "no irritation") based on standardized protocols rather than subjective interpretations requiring adjudication among multiple human reviewers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This document pertains to non-AI-powered examination gloves.

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

This information is not applicable. The device is a physical product (examination gloves), not an algorithm or software requiring a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the performance of the examination gloves is established through:

Standardized Test Methods: Adherence to established industry standards like ASTM (e.g., D5151-19 for holes, D6319-19 for physical properties, D6124-06 for residual powder) and ISO (e.g., 10993-10 for irritation/sensitization, 10993-11 for systemic toxicity).
Objective Measurements: Quantitative measurements (e.g., length, width, thickness, tensile strength, elongation, residual powder amount) with defined acceptable ranges.
Biological Assessments: Standardized biological evaluations to determine irritation, sensitization, and systemic toxicity, with "no irritation," "no sensitization," and "no acute systemic toxicity" as the ground truth for biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This device is an examination glove, not an AI or machine learning model that requires a training set.

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

This information 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 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 28, 2021

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd % Evan Hu Marketing Manager Shanghai Mind-link Consulting Co., Ltd. 639 Jiaozhou Road Shanghai, Shanghai 200040 China

Re: K212290

Trade/Device Name: Examination gloves -Type C (Nitrile gloves) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 26, 2021 Received: July 30, 2021

Dear Evan Hu:

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.

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 Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212290

Device Name

Examination gloves-Type C (Nitrile gloves)

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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Section 5.

510(k) Summary – K212290

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1. Submitter

Manufacturer: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. Address: No. 316 National road, Xinju, Changshan Town, Jinxian County, Nanchang City, 331724 Jiangxi Province, China. Contact person: Jenny Huang, 86-17702094798, 3454867077@qq.com Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net, 639 Jiaozhou Road, Shanghai, 200040, China

2. Device

Trading name: Examination gloves – Type C (Nitrile gloves) Common name: Nitrile patient examination glove Classification name: Polymer patient examination glove Classification: Class I Product code: LZA

3. Predicate device

Primary device: Powder Free Nitrile Examination Glove (Aqua Green) (K200326)

4. Device description

Size	S	M	L	XL
Length, mm	≥220	≥230	≥230	≥230
Width, mm	80±10	90±10	100±10	≥110
Thickness of Palm*, mm	0.080	0.080	0.080	0.080
Thickness of Finger*, mm	0.150	0.150	0.150	0.150

Table 1. Gloves specifications

*The minimum thickness of palm and finger

5. Indication for use

The Examination Gloves-Type C (Nitrile gloves) 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.

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6. Technological Characteristic Comparison between proposed and predicate devices

Characters	Proposed device (K212290)	Predicate device (K200326)	Comparison
Product code	LZA	LZA	Same
Intendeduse/Indicationsfor Use	The Examination Gloves-Type C(Nitrile gloves) is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner.	A powder free patient examinationglove is a disposable deviceintended for medical purposes thatis worn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner.The device is for over- the- counteruse.	Same
Prescriptionor over-the-counter use	Over-the-counter use	Over-the-counter use	Same
Material	Nitrile compound	Nitrile compound	Same
Color	Blue	Aqua green	Different
Sterility	Non-sterilized	Non-sterilized	Same
Single-use	Single-use	Single-use	Same
Dimensions	Size S, M, L, XL, meet ASTMD6319-19	Size S, M, L, XL, meet ASTM D6319-10	Same
Physicalproperties	Before and after aging properties,meet ASTM D6319-19	Before and after aging properties,meet ASTM D6319-10	Same
Freedomfrompinholes	Meets ASTM D5151-19, AQL 2.5	Meets ASTM D5151-06, AQL 2.5	Same
Residualpowder	Meets ASTM D6124-06,<2mg/glove	Meets ASTM D6124-06,<2mg/glove	Same
Biocompatibility	Non-irritant, meet ISO 10993-10Non-sensitizing, meet ISO 10993-10Non-cytotoxic, meet ISO 10993-11	Non-irritant, meet ISO 10993-10Non-sensitizing, meet ISO 10993-10Non-cytotoxic, meet ISO 10993-11	Same

Table 2. Characteristics comparison

7. Summary of Non-Clinical Testing

The non-clinical tests of this proposed device are tested in conformance with the following standards:

(a) ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves

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(b) ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application
(c) ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
(d) ASTM D412-16, Standards test method for Vulcanized Rubber and Thermoplastics Elastomer - Tension
(e) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization
(f) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
(g) ISO 28590:2017, Sampling Procedure for Inspection by Attributes
(h) ASTM D7160-16, Standard Practice for Determination of Expiration Dating for Medical Gloves
(i) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.

The performance and biocompatibility testing results are shown in Table 3.

Standard	Test Description	Acceptance criteria	Results
ASTM D5151-19	Freedom from holes	No water leakage (0 pinhole)	0 pinhole found
ASTM D6319-19	Physical Dimension	Multi acceptance criteria refer to ASTM D6319 Clause 7.4- TABLE 2.	Meet requirements. Refer to Table 4 below.
ASTM D6319-19, physical requirements	Tensile strength	Multi acceptance criteria refer to ASTM D6319 Clause 7.5- TABLE 3.	Meet requirements. Refer to Table 5 below.
ASTM D6124-06	Residual powder	≤2.0 mg/glove	0.10mg/glove (before aging)0.12mg/glove (after aging)
ISO 10993-10:2010	Skin sensitization and irritation	No irritation and skin sensitization	No irritation and skin sensitization
ISO 10993-11:2017	Systemic toxicity	No acute systemic toxicity	No acute systemic toxicity

Table 3. A summary of the performance/biocompatibility testing results.

Table 4. Gloves size testing before and after aging, according to ASTM D6319

Size	S	M	L	XL
Before aging
Length, mm	240	241	246	250
Width, mm	86	95	104	114
Minimum thickness ofPalm, mm	0.086	0.087	0.087	0.087
Minimum thickness ofFinger, mm	0.150	0.150	0.150	0.150

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After aging at 60 °C for 158 days
Length, mm	240	241	246	250
Width, mm	86	95	104	114
Minimum thickness ofPalm, mm	0.086	0.087	0.087	0.087
Minimum thickness ofFinger, mm	0.150	0.150	0.150	0.150

Table 5. Gloves physical properties, pinhole testing results, and residual powder, before and after aging.

Size	S	M	L	XL
Before aging
Tensile strength (MPa)	32	33	33	34
Elongation at break (%)	566	574	576	585
After aging at 60 °C for 158 days
Tensile strength (MPa)	32	33	32	34
Elongation at break (%)	545	556	561	564

Clinical testing data is not applicable in this case.

8. Conclusion

The conclusions drawn from the non-clinical testing results demonstrates that the proposed device, Examination gloves – Type C (Nitrile gloves), is as safe, as effective and performs as well as or better than the legally marketed predicate device that cleared under K200326.

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.