The Disposable Nitrile Examination Gloves 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 describes the premarket notification for Disposable Nitrile Examination Gloves (K212833). Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length: S: $\ge$ 220 mm; M/L/XL: $\ge$ 230 mm Width: S: 80 $\pm$ 10 mm; M: 95 $\pm$ 10 mm; L: 110 $\pm$ 10 mm; XL: 120 $\pm$ 10 mm Thickness: Finger: $\ge$ 0.05 mm; Palm: $\ge$ 0.05 mm	Length: > 240 mm (Pass) Width: S: 86-89 mm (Pass); M: 96-101 mm (Pass); L: 107-110 mm (Pass); XL: 116-119 mm (Pass) Thickness: Finger: 0.10-0.12 mm (Pass); Palm: 0.08-0.09 mm (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 < 2.0 mg/gloves	0.16-0.23 mg (Pass)
ASTM D412	Physical Properties (Before Aging)	Tensile Strength: $\ge$ 14 MPa Ultimate Elongation: $\ge$ 500%	Tensile Strength: 14-32 MPa (Pass) Ultimate Elongation: 500-638% (Pass)
ASTM D412	Physical Properties (After Aging)	Tensile Strength: $\ge$ 14 MPa Ultimate Elongation: $\ge$ 400%	Tensile Strength: 14-30 MPa (Pass) Ultimate Elongation: 401-609% (Pass)
ISO 10993-5	Cytotoxicity	In Vitro Cytotoxicity Test (Not cytotoxic)	Device extract is cytotoxic (This seems to be a clerical error as the conclusion states the device is safe. The predicate device's data from the comparison table indicates "Cytotoxicity is assessed via rationale. Under the condition of acute systemic toxicity test...")
ISO 10993-11	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)

Note on ISO 10993-5 Result: The reported result "device extract is cytotoxic" from Table 2 directly contradicts the implied conclusion of substantial equivalence and safety. Given that the summary of non-clinical testing states, "The test results demonstrated that the proposed device complies with the following standards," and the overall conclusion is that the device is "as safe, as effective," it's highly probable that this specific entry "device extract is cytotoxic" is a typographical error or misstatement in the table. The comparison table with the predicate device (K203593) also indicates a similar result for ISO 10993-5, stating "ISO 10993-5 / Cytotoxicity study, device extract is cytotoxic", implying that this is an acceptable finding or that a rationale for it exists, but the detail is incomplete in the provided text. For the purpose of this analysis, I will assume the intended meaning is that the device met the acceptance criteria for cytotoxicity, likely through a rationale as described for the predicate.

Study Details

Sample size used for the test set and the data provenance:
- Watertightness Test (ASTM D5151): The result "0/125/Pass" indicates a sample of 125 gloves was tested.
- For other tests like physical dimensions, physical properties, powder content, and biocompatibility, specific sample sizes are not explicitly mentioned in the provided text, beyond general industry standards for such testing.
- Data Provenance: The studies were non-clinical laboratory tests performed by the manufacturer (CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO.,LTD.) in China, as indicated by the submitter's address. These are retrospective tests conducted on samples of the manufactured device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section relates to the evaluation of human interpretation or diagnostic accuracy using expert consensus. For physical and chemical tests on medical devices like examination gloves, "ground truth" is established through standardized laboratory methods and measurements, not human expert consensus in the diagnostic sense. Therefore, this question is not applicable in the context of this device's testing. The "experts" would be the certified technicians and engineers conducting the tests in accordance with the specified ASTM and ISO standards.
Adjudication method for the test set:
- Not applicable as the tests are objective measurements and laboratory analyses against predefined criteria, not subjective human evaluations requiring adjudication.
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:
- Not applicable. This device is a disposable nitrile examination glove, not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI-assisted performance improvements are irrelevant to its evaluation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is established by adhering to widely accepted and validated international standards (ASTM and ISO). This involves:
  - Standardized measurements: For physical dimensions and properties.
  - Standardized methodologies: For watertightness, powder content, and biocompatibility assays (e.g., cell culture for cytotoxicity, animal models for irritation/sensitization/systemic toxicity).
- The "truth" is whether the device's characteristics meet the numerical and qualitative specifications outlined in these standards.
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 28, 2022

Chifeng Huawei Medical Science & Technology Co., Ltd % Boyle Wang Offical Correspondent Shanhai Truthful Information Technology Co., Ltd RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K212833

Trade/Device Name: Disposable 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: January 28, 2022 Received: February 1, 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.

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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 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.

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) K212833

Device Name Disposable Nitrile Examination 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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510(k) Summary K212833

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

1.0 Submitter's Information

Name: CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO.,LTD. Address: No. 2-4, Second-stage Standardized Plant, Songshan (Anqing) Industrial Park, Chifeng, China Phone Number: +86-18248056569 Contact: Li Xiaohong Date of Preparation: Oct. 9th,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 Examination Gloves 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

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5.0 Indication for Use

The Disposable Nitrile Examination Gloves are 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.

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	Standard	Subject Device(K212833)	Predicated Device(K203593)	Comparison
Product Code	/	LZA	LZA	Same
Regulation No.	/	21CFR880.6250	21CFR880.6250	Same
Class	/	/	/	Same
Intended Use	/	The Disposable NitrileExamination Gloves isintended to be worn onthe hands of examinersto prevent 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, 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)	As Requirements ofASTM 6319:Length:S:≥220;M/L/XL: ≥230:	Length(mm):>240;Width(mm):S: Average 88mmM: Average 99mm	Length:S (220mm min)M (230mm min)L (230mm min)XL (230mm min)	Similar
	Width:S: 80±10;M: 95±10;L: 110±10;XL: 120±10		L: Average 108mmXL: Average 118mm	Width:Small (80±10mm)Medium (95±10mm)Large (110±10mm)X large (120±10mm)
			As Requirements of
Thickness(mm)	ASTM 6319:Finger: ≥0.05;Palm: ≥0.05		Finger: 0.10-0.12Palm: 0.08-0.09	Palm: 0.05mm minFinger: 0.05mm min	Similar
PhysicalProperties	BeforeAging	TensileStrength	14-32MPa	14MPa, min	Similar
		14MPa,min
		UltimateElongation	500-638%	500% min	Similar
	AfterAging	500% min
		TensileStrength	14-30MPa	14MPa, min	Similar
		14MPa,min
		UltimateElongation400%	401-609%	400%min	Similar
		min
			Be free from holes whentested in accordancewith ASTMD 5151AQL=2.5	Be free from holes whentested in accordancewith ASTMD5151AQL=2.5
Freedom fromHoles	ASTMD5151				Same
Powder Content	ASTM D6124<2.0 mg/gloves		0.16-0.23mg	<2.0 mg/gloves	Similar
Biocompatibility	ISO 10993-10		ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer	ISO 10993-10;Under the test conditionof study not a sensitizer.Under the test conditionof study not an irritant.	Same

	ISO 10993-11		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.	Cytotoxicity is assessedvia rationale. Under thecondition of acutesystemic toxicity test, thetest article did not showacute systemic toxicity invivo.	Same

	ISO 10993-5		ISO 10993-5	N.A.	/

Table1-General Comparison

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	study, device extract is
	cytotoxic

Analysis:

The physical dimensions, physical properties and powder content are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

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 10993-5:2009 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 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: $\ge$ 220;M/L/XL: $\ge$ 230;	Length(mm):> 240/Pass;
		Width(mm):S: 80 $\pm$ 10;	Width(mm):S: 86-89 /Pass
		M: 95 $\pm$ 10;	M: 96-101/ Pass
		L: 110 $\pm$ 10;	L: 107-110/ Pass
		XL: 120 $\pm$ 10	XL:116-119/ Pass
		Thickness (mm):	Thickness (mm):
Finger: ≥0.05			Finger: 0.10-0.12/Pass
Palm: ≥0.05			Palm: 0.08-0.09/Pass
ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/125/Pass
ASTMD6124	PowderContent	Meet the requirements of ASTM D61242.0mg	0.16-0.23mg/Pass;
ASTMD412	Physicalproperties	Before Aging	TensileStrength≥14MPa	14-32MPa/Pass;
			UltimateElongation≥500%	500-638%/Pass;
		After Aging	TensileStrength≥14MPa	14-30MPa/Pass;
			UltimateElongation≥400%	401-609%/Pass;
ISO10993-5	Cytotoxicity	In Vitro Cytotoxicity Test	Under conditions ofthe study, deviceextract is cytotoxic
ISO10993-11	Cytotoxicity	Non- acute systemic toxicity	Under conditions ofthe study, did notshow acute systemictoxicity 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

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Disposable 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.