Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves (Non-Sterile). This type of document is for a medical device that does not use AI/ML, and therefore, the requested information regarding AI/ML device performance and related study details is not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance/Result
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test	To determine the width, length, and thickness of the gloves	Width:80mm ±10mm (for small size)95mm ±10mm (for medium size)110 mm ±10mm (for large size)Length:220 mm (Minimum) (for small size)230 mm (Minimum)(for medium, large size)Thickness:Finger -0.05 mm (Minimum) (for small, medium, large size)Palm -0.05 mm (Minimum)(for small, medium, large size)	Width:small size: 82 to 89mmmedium size: 91 to 96mmlarge size: 115 to 116mmLength:small size: 230mm (minimum)medium size: 240mm (minimum)large size: 238mm (minimum)Thickness:Finger:small size: 0.12mm (minimum)medium size: 0.13mm (minimum)large size: 0.12mm (minimum)Palm:small size: 0.08 mm (minimum)medium size: 0.08mm (minimum)large size: 0.09 mm (minimum)Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test	To determine the tensile strength and ultimate elongation before and after acceleration aging	Before Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 500 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 400 (Minimum)	Before Acceleration Aging:Tensile Strength (MPa): 20 (Minimum)Ultimate Elongation (%): 521 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 19 (Minimum)Ultimate Elongation (%): 505 (Minimum)Passed
ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves	To determine the holes in the gloves	(Mean) AQL 2.5	Passed
ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves	To determine the residual powder in the gloves	< 2.0 mg/glove	0.33 mg/glove, Passed
ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization	To determine the potential of the material under test to produce skin irritation in rabbits	Under the condition of study, testing articles are not an irritant	Under the conditions of study, the test article did not show significant evidence of causing skin sensitization in the guinea pig. (Note: Result listed under the "irritation" row in the document is the sensibility test result for the guinea pig).
ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization	To determine the skin sensitization potential of the material both in terms of induction and elicitation in guinea pigs.	Under the conditions of the study, the testing articles are not a sensitizer.	Under the conditions of the study the sample did not induce skin irritation. (Note: Result listed under the "sensitization" row in the document is the irritation test result).
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity	To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method	Under the conditions of study, no more than grade 2 cytotoxic reaction	Mild (Grade 2) cytotoxicity reaction observed. Passed.

Since this document describes a Class I medical device (Disposable Medical Nitrile Examination Gloves), which is a low-risk device, the requirements for its acceptance parallel those of general product testing and biocompatibility, as opposed to complex AI/ML algorithms. Therefore, the following points regarding AI/ML specific study information are not applicable to this submission:

Sample sizes used for the test set and the data provenance: Not applicable. Testing involves physical properties and biocompatibility, not data sets for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves (e.g., tensile strength, freedom from holes) is established through standardized physical and chemical testing, not expert interpretation of AI outputs.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on established material science and biological testing standards (e.g., ASTM and ISO standards) which define performance metrics for physical properties (e.g., length, width, thickness, tensile strength, elongation), chemical properties (e.g., powder residue), and biological responses (e.g., skin irritation, sensitization, cytotoxicity).
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. This is not an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 18, 2021

Sugian Linglian Medical Technology Co., Ltd % Johnson Liu Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, OLD 4122 Australia

Re: K212600

Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Non-sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 6, 2021 Received: August 17, 2021

Dear Johnson Liu:

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.

{1}------------------------------------------------

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, 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K212600

Device Name

Disposable Medical Nitrile Examination Gloves (Non Sterile)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary (K212600)

Disposal Medical Nitrile Examination Gloves (Non Sterile)

Preparation Date: Aug 6th, 2021

1. SUBMITTER

Company Name: SUQIAN LINGLIAN MEDICAL TECHNOLOGY CO.. LTD Company Address: No 1 Rd Wanpi Industrial Park, Xinshuguan Road, Shuyang County, Suqian Jiangsu, CN 223699 Contact Person: Johnson Liu Telephone Number: +614-0158-9995 Email: Johnson(@cnmed.com.au

2. NAME OF THE DEVICE

Trade Name / Proprietary Name: Disposable Medical Nitrile Examination Gloves (Non Sterile) Device Name: Disposable Medical Nitrile Gloves Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA

3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Predicate Device: K203191 Applicant: Nathan Trading Co., Ltd Device Name: LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE OF THE DEVICE

Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

{4}------------------------------------------------

6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES

	DEVICE PERFORMANCE		REMARKS
CHARACTERISTICS	SUBJECT	PREDICATE
510(k) Number	Pending	K203191	-
	Disposable Medical Nitrile	LYDUS Nitrile Examination
Device Name	Examination Gloves (Non Sterile)	Gloves, Powder Free	-
Product Code	LZA	LZA	Same
Indications for Use	Disposable Medical NitrileExamination Gloves (Non Sterile) aredisposable devices intended formedical purpose that are worn on theexaminer's hand to preventcontamination between patient andexaminer. The device is for over the-counter use.	LYDUS Nitrile ExaminationGloves, Powder Free is adisposable deviceintended for medical purposesthat is worn on the examiner'shand or fingers to preventcontamination between patientand examiner.	Same
Materials of Use(ASTMD6910/D6910M-19)	Nitrile compound	Nitrile compound	Same
Color	Blue	Blue	Same
Texture	Finger Textured	Finger Textured	Same
Size(ASTM D6319-19)	Small, Medium, Large,	Small, Medium, Large,Extra Large	Same
Sterilization	Non-sterile	Non-sterile	Same
Usage	Single use	Single use	Same
Dimensions(ASTM D6319-19)	Length Min. 230 min Width Min95+/-10 mm (for medium size)	Length Min. 230 min Width Min95+/-10 mm (for medium size)	Same
Physical Properties(ASTM D6319-19)	Before AgingTensile StrengthMin 14 Mpa Ultimate ElongationMin 500%After AgingTensile StrengthMin 14 Mpa Ultimate ElongationMin 400%	Before AgingTensile StrengthMin 14 Mpa UltimateElongation Min 500%After AgingTensile StrengthMin 14 Mpa UltimateElongation Min 400%	Same
Thickness(ASTM D6319-19)	Palm min 0.05 mmFinger min 0.05 mm	Palm min 0.05 mmFinger min 0.05 mm	Same
Powder Free(ASTM D6319-19)	<2 mg/glove	<2 mg/glove	Same
Freedom from Holes (WaterTight -1000 ml) – ASTMD6319-19 (Cross ReferenceD5151) AQL 2.5	Passed	Passed	Same
Biocompatibility -SKIN SENSITIZATION -ISO 10993-10: 2010 (E)	Under the conditions of study, thetest article did not show significantevidence of causing skinsensitization in the guinea pig.	Under the conditions of studynot a sensitizer	Same
Biocompatibility -SKIN IRRITATION - ISO10993-10: 2010 (E)	Under the conditions ofthe study the sample did not induceskin irritation.	Under the conditions ofthe study not an irritant	Same
Biocompatibility - INVITRO CYTOTOXICITY -ISO10993-5: 2009(E)	Under the conditions of thecytotoxicity study, mildSystemic cytotoxicity (Grade 2)observed. It complied with thecriteria in ISO 10993-5:2009.	Exhibit cytotoxicreactivity at 100%extract concentration(Grade 4 with neat extract).Non-cytotoxicreactivity at 50%, 25%,12.5% and 6.25%extract concentration.	Similar
Manufacturer(s)	SUQIAN LINGLIANMEDICAL TECHNOLOGYCO., LTD	Nathan Trading Co., Ltd	------

{5}------------------------------------------------

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.

{6}------------------------------------------------

7. NON-CLINICAL TESTING SUMMARY

PERFORMANCE DATA

Test Method	Purpose	Acceptance Criteria	Result
ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalDimensions Test	To determine thewidth, length, andthickness of thegloves	Width:80mm ±10mm (for small size)95mm ±10mm (for medium size)110 mm ±10mm (for large size)Length:220 mm (Minimum) (for small size)230 mm (Minimum)(for medium, largesize)Thickness:Finger -0.05 mm (Minimum) (for small,medium, large size)Palm -0.05 mm (Minimum)(for small,medium, large size)	Widthsmall size82 to 89mmmedium size91 to 96mmlarge size115 to 116mmLengthsmall size230mm (minimum)medium size240mm (minimum)large size238mm (minimum)ThicknessFingersmall size0.12mm (minimum)medium size0.13mm (minimum)large size0.12mm (minimum)Palmsmall size0.08 mm (minimum)medium size0.08mm (minimum)large size0.09 mm (minimum)Passed
ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalRequirements Test	To determine thetensile strength andultimate elongationbefore and afteracceleration aging	Before Acceleration Aging:Tensile Strength (MPa):14 (Minimum)Ultimate Elongation (%):500 (Minimum)After Acceleration Aging:Tensile Strength (MPa):14 (Minimum)Ultimate Elongation (%):400 (Minimum)	Before Acceleration Aging:Tensile Strength (MPa):20 (Minimum)Ultimate Elongation (%):521 (Minimum)After Acceleration Aging:Tensile Strength (MPa):19 (Minimum)Ultimate Elongation (%):505 (Minimum)Passed
ASTM D6319-19(ASTM D5151-11)Standard Test Methodfor Detection of Holes inMedical Gloves	To determine theholes in the gloves	(Mean)AQL 2.5	Passed
ASMT D6319-19(ASTM D6124-11)Standard Test Methodfor Residual Powder onMedical Gloves	To determine theresidual powder inthe gloves	< 2.0 mg/glove	0.33 mg/glove, Passed
Test Method	Purpose	Acceptance Criteria	Result
ISO 10993-10 Biologicalevaluation of medicaldevices — Part 10: Testsfor skin irritation andskin sensitization	To determine thepotential of the materialunder test to produceskin irritation in rabbits	Under the condition ofstudy, testing articlesare not an irritant	Under the conditions ofstudy, the test article didnot show significantevidence of causing skinsensitization in the guineapig.
ISO 10993-10 Biologicalevaluation of medicaldevices — Part 10: Testsfor skin irritation and skinsensitization	To determine the skinsensitization potential ofthe material both interms of induction andelicitation in guinea pigs.	Under the conditions ofthe study, the testingarticles are not asensitizer.	Under the conditions ofthe study the sample didnot induce skin irritation.
ISO 10993-5 Biologicalevaluation of medicaldevices — Part 5: Testsfor in vitro cytotoxicity	To evaluate the in vitrocytotoxic potential of thetest item (both inner andouter surface) Extracts inL-929 mouse fibroblastscells using elutionmethod	Under the conditions ofstudy, no more thangrade 2 cytotoxicreaction	Mild (Grade 2)cytotoxicity reactionobserved.

{7}------------------------------------------------

BIO-COMPATIBILITY DATA

8.CLINICAL TESTING SUMMARY

Not applicable - Clinical data is not needed for gloves cleared by the 510(k) process.

9. CONCLUSION

The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Disposable Medical Nitrile Examination Gloves (Non Sterile) are as safe, as effective, and performs as well as or better than the legally marketed predicate device K203191- LYDUS Nitrile Examination Gloves, Powder Free.

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.