The Nitrile Examination Gloves,Green/ Blue/ Black Color are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is provided in color Green, Blue or Black. The subject device is nonsterile.

AI/ML Overview

This document pertains to the 510(k) premarket notification for Nitrile Examination Gloves, Green/Blue/Black Color (K211778). The information provided describes the device, its intended use, and a comparison to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are detailed in the "Summary of Non-clinical Testing" section (page 7 onwards) and specifically in the table.

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length (mm): Blue/Green Color: XS/S: ≥220, M/L/XL: ≥230; Black: S: ≥220, M/L/XL: ≥230. Width (mm): Blue/Green Color: XS:70±10; S:80±10; M:95±10; L:110±10; XL:120±10; Black Color: S:80±10; M:95±10; L:110±10; XL:120±10. Thickness (mm): Finger: ≥0.05, Palm: ≥0.05.	Length: >230 mm (for all sizes, exceeding the minimums). Width: - Green Color: XS:73~~76; S:80~~84; M:95~~99; L:108~~111; XL:114~~117. - Blue Color: XS:72~~75; S:85~~90; M:92~~98; L:108~~111; XL:110~~119. - Black Color: S:82~~90; M:93~~97; L:108~~111; XL:114~~116. Thickness (mm): - Green: Finger: 0.14-0.15, Palm: 0.12-0.14. - Blue: Finger: 0.12-0.13, Palm: 0.11-0.12. - Black: Finger: 0.15-0.16, Palm: 0.12-0.13. Result: Pass for all.
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5 (Acceptable Quality Level of 2.5 for freedom from holes).	Green: 0/125 leaks; Blue: 0/125 leaks; Black: 0/125 leaks. Result: Pass for all.
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0mg.	Green: 0.08 mg; Blue: 0.07 mg; Black: 0.08 mg. Result: Pass for all.
ASTM D412	Physical Properties (Tensile)	Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%. After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400%.	Before Aging: - Tensile Strength: Green: 14.5-16.1 MPa, Blue: 15.1-19.6 MPa, Black: 14.1-41.2 MPa. - Ultimate Elongation: Green: 559-953%, Blue: 745-927%, Black: 545-1193%. After Aging: - Tensile Strength: Green: 14.2-15.5 MPa, Blue: 14.5-15.6 MPa, Black: 14.0-21.8 MPa. - Ultimate Elongation: Green: 541-805%, Blue: 662-740%, Black: 533-797%. Result: Pass for all.
ISO 10993-5	Cytotoxicity	Non-cytotoxic.	Under conditions of the study, did not show potential toxicity to L-929 cells. Result: Pass.
ISO 10993-10	Irritation	Non-irritating.	Under the conditions of the study, not an irritant. Result: Pass.
ISO 10993-10	Sensitization	Non-sensitizing.	Under conditions of the study, not a sensitizer. Result: Pass.

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

The document does not explicitly state a specific "sample size for the test set" in the context of an AI/ML algorithm or a typical clinical trial test set. The tests performed are non-clinical performance tests on the physical product.

For Watertightness (ASTM D5151): The test involved a sample size of 125 units for each color (Green, Blue, Black). The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission, likely conducted in China given the submitter's address. This is retrospective data in the sense that it's reported from completed tests.

For other physical tests (dimensions, physical properties), the specific number of units or measurements per unit is not explicitly stated in this summary, but it would align with the requirements of the respective ASTM standards.

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

This document is a 510(k) submission for medical examination gloves, which are low-risk Class I devices. The studies performed are physical and biocompatibility tests, not studies involving expert interpretation of medical images or patient outcomes.

Therefore, no experts (e.g., radiologists) were used to establish ground truth in the context of typical AI/ML algorithm validation. The ground truth for these tests is based on objective physical measurements and chemical/biological assays defined by international and national standards (ASTM, ISO).

4. Adjudication Method for the Test Set

As the tests are objective physical and chemical/biological assessments, no adjudication method (like 2+1 or 3+1 for expert interpretations) was necessary or performed. The results are quantitative measurements against predefined criteria.

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

No MRMC study was done. This type of study is typically performed for diagnostic devices (e.g., AI for medical imaging) to assess how AI assistance impacts human reader performance. Examination gloves do not involve human diagnostic interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. This document describes a physical medical device (examination gloves), not an algorithm or AI system. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

The ground truth for this device's performance claims is based on objective measurements and laboratory testing against established industry standards:

Physical Standards: Adherence to ASTM D6319 (dimensions, physical properties), ASTM D5151 (freedom from holes), and ASTM D6124 (powder content).
Biocompatibility Standards: Adherence to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation, sensitization).

This is a form of "reference standard" based on published, peer-reviewed, and globally recognized test methodologies.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device. There is no AI/ML algorithm involved, and therefore no "training set."

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

Not applicable. As there is no training set, the question of its ground truth establishment is irrelevant in this context.

Summary

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September 2, 2021

Zhenjiang SuHui Latex Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.1601, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China

Re: K211778

Trade/Device Name: Nitrile Examination Gloves, Green/ Blue/ Black Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 2, 2021 Received: June 9, 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,

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211778

Device Name

Nitrile Examination Gloves,Green Color Nitrile Examination Gloves,Blue Color Nitrile Examination Gloves,Black Color

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 (K211778)

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

1.0 Submitter's Information

Name: Zhenjiang Suhui Latex Products Co., Ltd. Address: Lianhe Village, Xinba Town, Yangzhong City, Jiangsu Province, P.R.China 212212 Tell: +86-13805299882 Contact: Zhengfu Sun Date of Preparation: 09/02/2021

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:	Nitrile Examination Gloves,Green Color
	Nitrile Examination Gloves,Blue Color
	Nitrile Examination Gloves,Black Color
Common name:	Patient Examination Gloves
Classification name:	Non-powdered patient examination glove
Model(s):	Nitrile Examination Gloves, Green / Blue Color areavailable in XS,S,M,L,XL; Nitrile Examination Gloves,Black Color are available in 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

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Manufacturer:	Ever Global (Vietnam) Enterprise Corp
Device:	Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color
510(k) number:	K171422

5.0 Indication for Use

The Nitrile Examination Gloves,Green/Blue/Black Color are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is provided in color Green, Blue or Black. The subject device is nonsterile.

7.0 Technological Characteristic Comparison Table

Table1-General Comparison
Item	Subject Device(K211778)	Predicate Device(K171422)	Remark
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class			Same
Intended Use	The Nitrile ExaminationGloves,Green/Blue/BlackColor are disposabledevices intended formedical purposes thatare worn on theexaminer's hands toprevent contaminationbetween patient andexaminer.	The DisposablePowder Free NitrileExamination Glove,White/ Blue/ Black/Pink Color is adisposable deviceintended formedical purposesthat is worn on theexaminer's hands topreventcontaminationbetween patientand examiner.	Same
Powdered orPowdered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
LabelingInformation	Single-use indication,powder free, device	Single-useindication, powder	Same

Table1-General Comparison

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color, device name,glove size and quantity,Nitrile Glove PowderFree, Non-Sterile	free, device color,device name, glovesize and quantity,Disposable PowderFree NitrileExamination Glove,Non-Sterile
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Table2 Device Dimensions Comparison

Item	Subject device(K211778)	Predicated device(K171422)	Remark
Length, mm	Blue/Green:XS/S: ≥220M/L/XL: ≥230Black:S: ≥220M/L/XL: ≥230	XS/S/M/L/XL:≥230	Similar
Width, mm	Blue/Green Color:XS:70±10;S:80±10;M:95±10;L:110±10;XL:120±10Black Color:S:80±10;M:95±10;L:110±10;XL:120±10	XS:75±5;S:85±5;M:95±5;L:105±5;XL:115±5	Similar
Thickness, mm
Finger	0.05	0.05	Same
Palm	0.05	0.05	Same

Analysis: The physical dimensions are little 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.

Item	Subject device(K211778)	Predicate device(K171422)	Remark
Colorant	Green/ Blue/Black	White/ Blue/Black/ Pink	Different
Physical Before Tensile	14MPa, min	14MPa, min	Same

Table3 Performance Comparison

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Properties	Aging	Strength
	AfterAging	UltimateElongation	500% min	Same
		TensileStrength	14MPa, min	Same
		UltimateElongation	400%min	Same
		Comply with ASTM D6319	Comply withASTMD6319	Same
Freedom from Holes			Be free fromholes whentested inaccordancewithASTMD5151AQL=2.5	Same
Powder Content			Meet therequirementsof ASTMD6124	Same

Analysis: The proposed device has different colors as compared to the predicate device. To address this concern, biocompatibility test has been performed on proposed device and the test result can meet the requirements of ISO 10993 standards. Therefore, the differences will not raise any safety and effectiveness issues.

Table4 Safety Comparison

Item		Subject device(K211778)	Predicate device(K171422)	Remark
Material		Nitrile	Nitrile	Same
Biocompatibility	Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization)	Under the conditions ofthe study, notan irritant	Comply withISO10993-10	Same
	Sensitization(ISO 10993-10:2010Biological	Under conditions ofthe study, nota sensitizer.

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Evaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization)
Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity)	Underconditions ofthe study, /deviceextract is notcytotoxic	Similar

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 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

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.

TestMethodology	Purpose	Acceptance Criteria	Results
ASTM D6319	PhysicalDimensionsTest	Length(mm):	Length: >230
		Blue/Green Color:	Width:
		XS/S: ≥220,M/L/XL: ≥230	Green Color:
		Black:	XS:73~~76; S:80~~84;
		S: ≥220,M/L/XL: ≥230	M:95~~99; L:108~~111;
		Width(mm):	XL:114~117.
		Blue/Green Color:	Blue Color:
		XS:70±10; S:80±10;	XS:72~~75; S:85~~90;
		M:95±10; L:110±10;	M:92~~98; L:108~~111;

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		XL:120±10		XL:110~119.
		Black Color:		Black Color:
		S:80±10; M:95±10;		S:82~~90; M:93~~97 ;
		L:110±10; XL:120±10		L:108~~111;XL:114~~116.
				Pass
			Thickness (mm):	Green Color:
		Finger: ≥0.05		Finger: 0.14-0.15
		Palm: ≥0.05		Palm: 0.12-0.14
				Blue Color:
				Finger: 0.12-0.13
				Palm: 0.11-0.12
				Black Color:
				Finger: 0.15-0.16
				Palm: 0.12-0.13
				Pass
ASTM D5151	WatertightnessTestforDetectionofHoles	Meet the requirements ofASTM D5151 AQL 2.5		Green:0/125 leaksBlue:0/125 leaksBlack:0/125 leaksPass
ASTM D6124	PowderContent	Meet the requirements ofASTM D6124 < 2.0mg		Green:0.08 mg;Blue:0.07 mg;Black:0.08 mg;Pass
ASTM D412	Physicalproperties	BeforeAging	TensileStrength	≥14MPa	Green:14.5-16.1Blue:15.1-19.6Black:14.1-41.2Pass
			UltimateElongation	≥500%	Green:559-953Blue: 745-927Black:545-1193Pass

		AfterAging	TensileStrength	≥14MPa	Green:14.2-15.5Blue:14.5-15.6Black:14.0-21.8Pass
			UltimateElongation	≥400%	Green:541-805Blue: 662-740Black:533-797Pass

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ISO 10993-5	Cytotoxicity	Non-cytotoxic	Under conditions of thestudy, did not showpotential toxicity to L-929 cells.Pass
ISO 10993-10	Irritation	Non-irritating	Under the conditions ofthe study, not an irritant.Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of thestudy, not a sensitizer.Pass

9.0 Summary of Clinical Testing

Clinical testing is not needed for this device.

Conclusion 10.0

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Examination Gloves,Green/Blue/Black Color, are as safe, as effective, and performs as well as or better than the legally marketed predicated device under 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.