The Disposable Nitrile Powder-Free Examination Gloves 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 proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

AI/ML Overview

Based on the provided text, the device in question is "Disposable Nitrile Powder-Free Examination Gloves," which are Class I medical devices used to prevent contamination between patients and examiners. The document describes non-clinical performance testing rather than a study involving human subjects or AI, as would be typical for software or imaging devices.

Therefore, many of the requested categories for AI-based device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this premarket notification for examination gloves.

Here's the relevant information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for examination gloves.

Table of Acceptance Criteria and Reported Device Performance for Disposable Nitrile Powder-Free Examination Gloves:

Test	Methodology / Standard	Purpose	Acceptance Criteria	Reported Performance/Results
Biocompatibility
Irritation & Skin Sensitization	ISO 10993-10:2010	Assess possible contact hazards from chemicals, which may produce skin and mucosal irritation, eye irritation or skin sensitization.	Skin Sensitization Test: Provided grades less than 1, otherwise sensitization.Skin Irritation Test: Primary irritation index: 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe).	Skin Sensitization Test: All grades are 0. All animals survived with no abnormal signs observed.Skin Irritation Test: Primary irritation index is 0. Response categorized as negligible.
In Vitro Cytotoxicity	ISO 10993-5:2009	Assess the in vitro cytotoxicity of medical devices.	Viability reduced to <70% of the blank indicates cytotoxic potential.	Viab.% of 100% test article extract is 21.0%. The proposed device has potential toxicity to L-929 in the MTT method. (Note: Despite this, it was cleared, likely due to subsequent systemic toxicity testing and the nature of glove contact.)
Systemic Toxicity	ISO 10993-11:2017	Evaluate the potential for medical device materials to cause adverse systemic reactions.	Within 72 h, if the toxicosis response of testing group is not greater than that of control group, the testing sample is acceptable.	No evidence of systemic toxicity from the extract.
Physical/Performance Properties
Residual Powder on Medical Gloves	ASTM D6124-06 (Reapproved 2017)	Determine the amount of residual powder found on medical gloves (for powder-free distinction).	Powder residue limit of 2.0 mg.	0.09-0.11 mg/glove. (Meets criterion as it is well below 2.0mg)
Detection of Holes in Medical Gloves	ASTM D5151-06 (Reapproved 2015)	Cover the detection of holes in medical gloves.	Sample number: 125 gloves. AQL (Acceptable Quality Limit) = 2.5. Criterion ≤7 gloves for water leakage.	No glove water leakage found.
Specifications for Nitrile Exam Gloves	ASTM D6319-10 (Reapproved 2015)	Covers certain requirements for nitrile rubber gloves used in medical examinations and procedures.	Dimensions:- S: width 80±10mm, length ≥220 mm- M: width 95±10mm, length ≥230 mm- L: width 110±10mm, length ≥230 mm- XL: width 120±10mm, length ≥230 mmThickness: Finger ≥0.05 mm, Palm ≥0.05 mmPhysical properties:- Before aging: Tensile strength ≥14MPa, Ultimate Elongation ≥500%- After Accelerated Aging: Tensile strength ≥14MPa, Ultimate Elongation ≥400%	Dimensions (across multiple lots):- S: width 82-86 mm, length 245-255 mm- M: width 91-96 mm, length 245-256 mm- L: width 101-110 mm, length 252-261 mm- XL: width 111-120 mm, length 250-262 mm (All reported dimensions meet or exceed the min/range, considering tolerance analyses further down the document).Thickness (across multiple lots): Finger 0.11-0.12 mm, Palm 0.07-0.08 mm (All meet or exceed the minimum).Physical properties (across multiple lots):- Before aging: Tensile strength 15.2-24.4 MPa, Ultimate Elongation 525.655% - 798.544% (All meet or exceed required minimums).- After Accelerated Aging: Tensile strength 14.0-18.7 MPa, Ultimate Elongation 578.552% - 745.388% (All meet or exceed required minimums).

Study Details (Non-Clinical Performance Testing):

This document describes non-clinical performance testing of a physical device (examination gloves), not a study of an AI algorithm or human reader performance. Therefore, most of the requested fields are not applicable.

Sample size used for the test set and the data provenance:
- Freedom from Holes: 125 gloves. No specific country of origin is mentioned for the test samples; it's implied they are samples of the manufactured gloves. The testing is prospective as it's part of the product characterization for market submission.
- Other tests (Biocompatibility, Physical properties): Sample sizes are not explicitly stated for individual tests but are implied to be sufficient for compliance with the respective standards (e.g., ISO, ASTM). The data provenance is testing conducted by the manufacturer (Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.) or its contracted labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for device performance is established by standardized test methodologies and their objective measurements, not by expert consensus or interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human interpretation study.
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 not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is defined by adherence to established international and national standards (ASTM, ISO) for material properties, dimensions, and biological safety. This is based on objective measurements and laboratory testing results.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning model. The manufacturing process is implicitly "trained" over time to produce consistent results that meet standards.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.

In summary, this FDA 510(k) submission for examination gloves demonstrates substantial equivalence to a predicate device, primarily through non-clinical laboratory testing that shows compliance with relevant performance and safety standards. The regulatory pathway is not driven by AI model validation or human reader performance studies.

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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

December 13, 2021

Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No. 738,Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K213176

Trade/Device Name: Disposable Nitrile Powder-Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 8, 2021 Received: September 28, 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,

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) K213176

Device Name

Disposable Nitrile Powder-Free Examination Gloves

Indications for Use (Describe)

The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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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510(k) Summary K213176

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

1.0 submitter's information

Name: ANHUI ZHONG LIAN LATEX GLOVES MANUFACTURING CO., LTD. Address: GUZHEN ECONOMIC DEVELOPMENT ZONE BENGBU CITY ANHUI CHINA Phone Number: +86-13853370291 Contact: Kitty xu Date of Preparation: 2021.09.08

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device information

Trade name: Disposable Nitrile Powder-Free Examination Gloves

Common name: Patient Examination Gloves

Classification name: Non-powdered patient examination glove

S, M, L, XL Model(s):

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

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Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

510(k) number: K171422

5.0 Intended use

The Disposable Nitrile Powder-Free Examination Gloves 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

7.0 Summary comparing technological characteristics with predicate device

Item	Proposed device	Predicated device	Comparison
510(k) number	Pending	K171422
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The Disposable NitrilePowder-Free ExaminationGloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	The Disposable PowderFree Nitrile ExaminationGlove, White/ Blue/ Black/Pink Color is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	Same
Powdered or Powered free	Powdered free	Powdered free	Same
Design Feature	ambidextrous	ambidextrous	Same
Labeling Information	Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposableNitrile Powder-FreeExamination Gloves,	Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove,	Same

Table1-General Comparison

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	Non-Sterile	Non-Sterile
--	-------------	-------------	--

Predicate	Designation	Size				Tolerance
Device(K171422)		XS	S	M	L	XL
	Length, mm	230	230	230	230	230	min
	Width, mm	75	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05				min
	Palm	0.05				min
Proposed Device	Designation	Size				Tolerance
		S	M	L	XL
	Length, mm	220	230	230	230		min
	Width, mm	80	95	110	120		±10
	Thickness, mm:
	Finger	0.05				min
	Palm	0.05				min
Remark	Analysis 1

Table2 Device Dimensions Comparison

Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19.

Item			Proposed device	Predicated device	Remark
Colorant			blue	White/ Blue/ Black/ Pink	Analysis2
PhysicalProperties	BeforeAging	TensileStrength	14MPa, min	14MPa, min	SAME
		UltimateElongation	500%min	500%min	SAME
	AfterAging	TensileStrength	14MPa, min	14MPa, min	SAME
		UltimateElongation	400%min	400%min	SAME
		Comply with ASTM D6319		Comply with ASTM D6319	SAME
Freedom from Holes			Be free from holes when tested in accordance with ASTMD5151 AQL=2.5	Be free from holes when tested in accordance with ASTMD5151 AQL=2.5	SAME
Powder Content			0.09-0.11	Meet the requirements of ASTM D6124	SIMILAR

Table3 Performance Comparison

Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test.

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Item		Proposed device	Predicated device	Remark
Material		Nitrile	Nitrile	SAME
Biocompati	Irritation	Under the conditions of the study,not an irritant	Comply withISO10993-10	SAME
bility	Sensitization	Under conditions of the study, not asensitizer.
	Cytotoxicity	Under the conditions of the study,the device is potentially cytotoxic	Comply withISO10993-5	Analysis3
	Systemictoxicity	Under the conditions of the study,the device does not elicit a systemictoxicity response in the modelanimal.	Complies with ISO10993-11 Third edition2017-09
Label and Labeling		Meet FDA's Requirement	MeetRequirement	FDA's SAME

Table4 Safety Comparison

Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test.

8.0 Summary of Non-Clinical Performance Testing

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

	Table 5 Summary of Non-Clinical Performance Testing
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No.	Name of the TestMethodology / Standard	Purpose	Acceptance Criteria	Results
1	ISO 10993-10:2010Biological Evaluation OfMedical Devices - Part10: Tests For IrritationAnd Skin Sensitization.	This part of ISO10993 assessespossible contacthazards fromchemicalsreleased frommedical devices, which mayproduce skin andmucosal irritation,eye irritation orskin sensitization.	Skin SensitizationTest:providedgrades less than 1,otherwisesensitization.	All grades are 0.All animals were survived and noabnormal signs were observedduring the study.
2			Skin Irritation Test:If the primary irritationindex is 0-0,4, theresponse category isNegligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe	The primary irritation index is 0.The response of the proposeddevice was categorized asnegligible under the testcondition

3	ISO 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity	This part of ISO10993 describestest methods toassess the in vitrocytotoxicity ofmedical devices.	The viab.% of the100% extract of thetest article is the finalresult, and if viability isreduced to <70% ofthe blank, it hascytotoxic potential.	Viab.% of 100% test articleextract is 21.0%It means the proposed devicehave potential toxicity to L-929 inthe MTT method
4	ISO 10993-11: 2017Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity	To evaluate thepotential formedical devicematerials to causeadverse systemicreactions.	Within the monitoringperiod (72 h), if thetoxicosis response oftesting group is notgreater than that ofcontrol group, thetesting sample isregarded asacceptable.	There was no evidence ofsystemic toxicity from the extract.
5	ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves	This standard isdesigned todetermine theamount ofresidualpowder (orfilter-retainedmass) foundon medical gloves	powder residue limit of2.0 mg	0.09-0.11 mg /glove
6	ASTMD5151-06(Reapproved2015), Standard TestMethod for Detection ofHoles in Medical Gloves.	This test methodcovers thedetection of holesinmedical gloves.	Samples number: 125glovesAQL: 2.5 (ISO 2859)Criterion ≤7 glovesfor water leakage	no glove water leakage found

7	ASTMD6319-10(Reapproved2015),StandardSpecification For NitrileExamination Gloves ForMedical Application.	This specificationcovers certainrequirements fornitrile rubbergloves used inconductingmedicalexaminations anddiagnostic andtherapeuticprocedures.	Sterility: no needFreedom from holes:pl. Refer to No. 5 intable 5Dimensions:S: width 80±10mmLength ≥220 mmM: width 95±10mmLength ≥230 mmL: width 110±10mmLength ≥230 mmXL: width 120±10mmLength ≥230 mmThickness:Finger ≥0.05 mmPalm ≥0.05 mm	N.A.Please refer to No. 5 in table 5Lot no.:210515Dimensions:S: width: 82-85 mmLength 245-254 mmM: width 91-94 mmLength 249-255 mmL: width 102-105 mmLength 252-260 mmXL: width 112-115 mmLength 250-262 mmThickness:Finger 0.11-0.12 mmPalm 0.08 mm
			Physical properties:Before agingTensile strength ≥14MPaUltimate Elongation >500%After AcceleratedAgingTensile strength ≥14MPaUltimate Elongation >400%Powder-free Residue:pl. Refer to No. 4 intable 5	Physical properties:Before agingTensile strength 15.2-17.6 MPaUltimate Elongation 629.928% -788.321%After Accelerated AgingTensile strength 14.2-18.7MPaUltimate Elongation 601.793% -738.384%Powder-free Residue:pl. Refer to No. 4 in table 5Lot no.:210518Dimensions:S: width: 83-85 mmLength 252-255 mmM: width 91-96 mmLength 250-256 mmL: width 101-106 mmLength 254-261 mmXL: width 111-116 mmLength 254-258 mmThickness:Finger 0.11mmPalm 0.08mm

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		Physical properties:Before agingTensile strength 17.1-24.4 MPaUltimate Elongation 525.655% -750.940%After Accelerated AgingTensile strength 14.0-18.1MPaUltimate Elongation 578.552% -755.773%Powder-free Residue:pl. Refer to No. 4 in table 5Lot no.:210520Dimensions:S: width: 82-86 mmLength 246-250 mmM: width 92-93mmLength 245-249 mmL: width 103-107 mmLength 252-259 mmXL: width 112-116 mmLength 254-258 mmThickness:Finger 0.11-0.12 mmPalm 0.07-0.08 mmPhysical properties:Before agingTensile strength 16.1-19.8 MPaUltimate Elongation 668.374% -798.544%After Accelerated AgingTensile strength 14.5-18.4MPaUltimate Elongation 621.273% -745.388%Powder-free Residue:pl. Refer to No. 4 in table 5

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9. Summary of Clinical Performance Test

No clinical study is included in this submission.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.

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.