The Medical Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

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

AI/ML Overview

The provided text describes the 510(k) summary for the "Medical Nitrile Examination Gloves" (K220066). This document is for a Class I medical device (non-powdered patient examination glove), which is a low-risk device. For such devices, clinical testing is typically not required, and the focus of the submission is on non-clinical performance and substantial equivalence to a predicate device.

Therefore, the requested information regarding AI device performance, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this specific submission. This document details the testing of physical properties and biocompatibility of examination gloves, not an AI or imaging device.

However, I can extract the acceptance criteria and performance data for the glove product based on the provided non-clinical testing summary.

Here's the relevant information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, for Medical Nitrile Examination Gloves)

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319 - Physical Dimensions Test
Length (mm)		S: ≥220; M/L/XL: ≥230	S: ≥220; Pass M/L/XL: ≥230; Pass
Width (mm)		S: 80±10; M: 95±10; L: 110±10; XL: 120±10	S: 83-88 /Pass M: 93-96/ Pass L: 104-109/ Pass XL: 110-116/ Pass
Thickness (mm)		Finger: ≥0.05; Palm: ≥0.05	Finger: 0.102-0.117/Pass Palm: 0.068-0.073/Pass
ASTM D5151 - Watertightness Test	For Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125/Pass (This implies 0 failures out of 125 samples tested)
ASTM D6124 - Powder Content		Meet the requirements of ASTM D6124 < 2.0mg	0.22mg/Pass
ASTM D412 - Physical Properties	Before Aging	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500%	Tensile Strength: 22.1-35.9 MPa/Pass; Ultimate Elongation: 505-588%/Pass
	After Aging	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400%	Tensile Strength: 21.4-44.3MPa/Pass; Ultimate Elongation: 452-540%/Pass
ISO 10993-5 - Cytotoxicity		Device extract is cytotoxic (This seems to be a reporting of a finding, not an "acceptance criteria" for passing submission, but rather a characteristic. Given no other remarks, it likely indicates the test was performed, and the output confirmed, but not necessarily a "pass/fail" in the typical sense for this specific line. However, the ISO 10993-11 for systemic toxicity and ISO 10993-10 for irritation/sensitization are clearly "pass" for safety.)	Under conditions of the study, device extract is cytotoxic. (Note: For medical devices, this often means the extract was confirmed to cause a cytotoxic effect in vitro, and further evaluation/mitigation or context like the specific application/contact duration, and other biocompatibility tests like irritation and sensitization, inform the overall safety profile.)
ISO 10993-11 - Systemic Toxicity	Non-acute systemic toxicity	N/A (implicit acceptance is non-toxicity)	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10 - Irritation	Non-irritating	N/A (implicit acceptance is non-irritating)	Under the conditions of the study, not an irritant/ Pass
ISO 10993-10 - Sensitization	Non-sensitizing	N/A (implicit acceptance is non-sensitizing)	Under conditions of the study, not a sensitizer./ Pass

Points 2-9 are not applicable to this submission as it is not for an AI / imaging device.

Regarding the "study that proves the device meets the acceptance criteria," the "Summary of Non-clinical Testing" (Section 8.0) and "Table 2 - Summary of non-clinical performance testing" provide the evidence.

Sample sizes used for the test set and data provenance:
- For the Watertightness Test (ASTM D5151), the result "0/125/Pass" implies a sample size of 125 gloves were tested.
- Other tests (e.g., physical dimensions, strength, thickness, powder content, biocompatibility) would have specific sample sizes per the ASTM/ISO standards, but these are not explicitly stated in the summary table beyond the result itself (e.g., "S: 83-88 /Pass").
- Data provenance: Not explicitly stated, but typically non-clinical testing for medical devices is performed by accredited labs, often in the country of manufacture (China, in this case, as per the submitter's address). This is retrospective for the purpose of the submission.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. These are laboratory tests measuring physical and chemical properties, not human interpretation of images or clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
The type of ground truth used:
- For physical/chemical tests: The "ground truth" is defined by the technical specifications and methodologies outlined in the referenced ASTM and ISO standards (e.g., specific measurement techniques, chemical analyses, biological assays).
- For biocompatibility tests: The "ground truth" is based on the biological responses observed in the in vitro and in vivo models as per ISO 10993 standards.
The sample size for the training set: Not applicable (this is not an AI/ML device).
How the ground truth for the training set was established: Not applicable.

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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 3, 2022

Hunan Zhenheyikang Medical Instrument 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: K220066

Trade/Device Name: 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 29, 2021 Received: January 10, 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220066

Device Name Medical 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 K220066

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

1.0 Submitter's Information

HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD Name: Address: No.6 Building Jingxiang Energy,No.55 Xiaguang East Road,Gaoxin District, Xiangtan, Hunan, China Phone Number: +86-0731-58262222 Contact: Yilin Yin Date of Preparation: Dec.29, 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: Medical 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: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color 510(k) number: K171422

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5.0 Indication for Use

6.0 Device Description

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

7.0 Technological Characteristic Comparison Table

	ANTATSubject Device	1114611991Predicated Device	Remark
ltem	(K220066)	(K171422)
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class			Same
	The Medical Nitrile	The Nitrile Powder Free	Same
	Examination Glove is a	patient examination
	non-sterile disposable	glove is a non-sterile
	device intended for	disposable device
	medical purposes that is	intended for medical
Intended Use	worn on the examiner's	purposes that is worn on
	hands or finger to	the examiner's hands or
	prevent contamination	finger to prevent
	between patient and	contamination between
	examiner.	patient and examiner.
Material	Nitrile	Nitrile	Same
Powdered or	Powdered free		Same
Powered free		Powdered free
Design Feature	Ambidextrous	Ambidextrous	Same
	Blue	White/Blue/ Black/ Pink	Different
Colorant			Analysis 1
LabelingInformation	Single-useindication,	Single-useindication,	Same
	free,powderdevice	free,powderdevice
	color.devicename.	color.devicename.
	glove size and quantity,	glove size and quantity,
	Non-Sterile	Non-Sterile
	Length:	Length:	Different
Dimensions(mm)	S: ≥220;	XS/S/M/L/XL: ≥230;	Analysis 2
		M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;XL: 120±10.	Width:XS: 87±5;S: 85±5;M: 95±5;L: 105±5;XL: 115±5
Thickness(mm)		Finger: ≥0.05;Palm: ≥0.05	Finger: ≥0.05;Palm: ≥0.05	Same

PhysicalProperties	BeforeAging	Tensile Strength14MPa, minUltimate Elongation500% min	Tensile Strength14MPa, minUltimate Elongation500% min	Same

	AfterAging	Tensile Strength14MPa, minUltimate Elongation400%min	Tensile Strength14MPa, minUltimate Elongation400%min	Same

Freedom fromHoles		Be free from holes when tested in accordance with ASTMD5151AQL=2.5	Be free from holes when tested in accordance with ASTMD5151AQL=2.5	Same
Powder Content		Meet the requirements of ASTM D6124	Meet the requirements of ASTM D6124	Same
Biocompatibility		ISO 10993-5Under conditions of the study, device extract is cytotoxic	N.A.	/
		ISO 10993-10;Under the conditions of the study, not an irritant or a sensitizer	ISO 10993-10;Under the conditions of the study, not an irritant or a sensitizer	Same
		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.	N.A.	/

Table1-General Comparison

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Analysis 1: The subject device (Blue) has different color to the predicate device (White/ Blue/ Black/ Pink), 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 D6319.

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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):	Length(mm):
		S: ≥220;	S: ≥220; Pass
		M/L/XL: ≥230;	M/L/XL: ≥230; Pass
		Width(mm):	Width(mm):
		S: 80±10;	S: 83-88 /Pass
		M: 95±10;	M: 93-96/ Pass
		L: 110±10;	L: 104-109/ Pass
		XL: 120±10.	XL:110-116/ Pass
		Thickness (mm):	Thickness (mm):
		Finger: ≥0.05Palm: ≥0.05	Finger:0.102-0.117/PassPalm:0.068-0.073/Pass
ASTMD5151	WatertightnessTestforDetection of	Meet the requirements of ASTM D5151AQL 2.5	0/125/Pass

Table 2 - Summary of non-clinical performance testing

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	Holes
ASTMD6124	PowderContent		Meet the requirements of ASTM D6124 < 2.0mg		0.22mg/Pass;
ASTMD412	Physicalproperties	BeforeAging	TensileStrength	≥14MPa	22.1-35.9 MPa/Pass;
			UltimateElongation	≥500%	505-588%/Pass;
		AfterAging	TensileStrength	≥14MPa	21.4-44.3MPa/Pass;
			UltimateElongation	≥400%	452-540%/Pass;
ISO10993-5	Cytotoxicity	toxicity			Under conditions ofthe study, deviceextract is cytotoxic.
ISO10993-11	Cytotoxicity	Non- acute systemictoxicity			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

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 Medical Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K171422.

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.