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

AI/ML Overview

The provided document describes the acceptance criteria and study results for "Disposable Medical Nitrile Gloves." Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319-19 - Physical Dimensions Test	To determine the width, length, and thickness of the gloves	Width: 80 ± 10 mm (small)95 ± 10 mm (medium)110 ± 10 mm (large)Length: (Minimum)220 mm (small)230 mm (med, large)Thickness: (Minimum)Finger - 0.05 mm (all sizes)Palm - 0.05 mm (all sizes)	Passed
ASTM D6319-19 - Physical Requirements Test	To determine the tensile strength and ultimate elongation before and after acceleration aging	Before Aging:Tensile Strength: 14 MPa (Min)Ultimate Elongation: 500% (Min)After Aging:Tensile Strength: 14 MPa (Min)Ultimate Elongation: 400% (Min)	Passed
ASTM D6319-19 (ASTM D5151-11) - Detection of Holes in Medical Gloves	To determine the holes in the gloves	(Mean) AQL 2.5	Passed
ASTM D6319-19 (ASTM D6124-11) - Residual Powder on Medical Gloves	To determine the residual powder in the gloves	≤ 2.0 mg/glove	0.1 mg/glove, Passed
ISO 10993-10 - Skin Irritation	To determine the potential of the material to produce skin irritation in rabbits	Under the condition of study not an irritant	Under the condition of study not an irritant
ISO 10993-10 - Skin Sensitization	To determine the skin sensitization potential of the material in guinea pigs	Under the conditions of the study not a sensitizer.	Under the conditions of the study not a sensitizer.
ISO 10993-5 - In Vitro Cytotoxicity	To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts	Under the conditions of study, no more than grade 2 cytotoxic reaction	Mild (Grade 2) cytotoxicity reaction observed.
ISO 10993-11:2017 - Acute Systemic Toxicity (in ICR Mice)	The test item was evaluated for acute systemic toxicity in ICR Mice	Under the conditions of the study no systemic toxicity	Under the conditions of the study no systemic toxicity

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical dimensions, number of animals for biocompatibility). It generally refers to the standards (e.g., ASTM D6319-19, ISO 10993 series) which inherently define sample size requirements for those tests. The data provenance is from tests conducted on the subject device, "Disposable Medical Nitrile Gloves," by Jiangsu Health-Peace Medical Technology Co. Ltd. It is retrospective in the sense that the tests were completed and reported to demonstrate compliance for premarket notification. The country of origin for the manufacturing and testing is not explicitly stated as separate from the company's address in China, but the submitting company is based in China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a medical glove, and the "ground truth" for its performance is established through standardized laboratory testing (physical, chemical, and biological tests) rather than expert interpretation of medical images or clinical outcomes. The performance is objectively measured against specified criteria in established standards like ASTM and ISO.

4. Adjudication Method for the Test Set

Not applicable. As described above, the testing involves objective measurements against predefined criteria, not subjective interpretation requiring adjudication.

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

Not applicable. This type of study is relevant for diagnostic or interpretive devices where human readers (e.g., radiologists) interact with the device's output. Medical gloves are not diagnostic devices, and there is no "human reader" component in their performance evaluation in this context.

6. Standalone Performance Study

Yes, standalone performance studies were done. The "PERFORMANCE DATA" section and "BIO-COMPATIBILITY DATA" section detail the results of various tests conducted on the "Disposable Medical Nitrile Gloves" alone. These tests directly measure the device's characteristics against the specified acceptance criteria of recognized standards without human intervention in the loop for assessment.

7. Type of Ground Truth Used

The ground truth used for these tests is defined by established International Standards and Specifications. Specifically:

ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-11: Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-11: Standard Test Method for Residual Powder on Medical Gloves.
ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization.
ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
ISO 10993-11:2017: Biological evaluation of medical devices — Part 11: Tests for acute systemic toxicity.

These standards provide objective, measurable criteria that serve as the "ground truth" for the device's performance and safety.

8. Sample Size for the Training Set

Not applicable. This is a conventional medical device (physical product) and not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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

Not applicable, as there is no training set for this device.

Summary

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

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.

August 17, 2021

Jiangsu Health-Peace Medical Technology Co. Ltd % Johnson Lui Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia

Re: K211708

Trade/Device Name: Disposable Medical Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 30, 2021 Received: August 3, 2021

Dear Johnson Lui:

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 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, 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 Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K211708

Device Name Disposable Medical Nitrile Gloves

Indications for Use (Describe)

Disposable Medical Nitrile Gloves are disposable device intended for medical purpose that is worn on the examiner's hand 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)

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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word HISIANMT in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The font is black and the background is white. The letters are thick and have a uniform width.

510(k) Premarket Notification

510(K) Summary

K211708

Disposable Medical Nitrile Gloves

Preparation Date: Aug 18th, 2021

1. SUBMITTER

Company Name: JIANGSU HEALTH-PEACE MEDICAL TECHNOLOGY CO. LTD Company Address: DongAn Youdian Street, Huangli Town, Wujin, Changzhou, CN 213155

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 Gloves 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. INTENDED USE/Indications for Use

Disposable Medical Nitrile Gloves is a 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
CHARACTERISTICS	SUBJECT	PREDICATE	REMARKS
510(k) Number	K211708	K203191	-
Device Name	Disposable Medical Nitrile Gloves	LYDUS Nitrile ExaminationGloves, Powder Free	-
Product Code	LZA	LZA	Same
Intended Use	Disposable Medical Nitrile Gloves isdisposable 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 patient 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 usage	Single usage	Same
Dimensions(ASTM D6319-19)	Length Min. 220 min Width Min80+/-10 mm (for small size)Length Min. 230 min Width Min95+/-10 mm (for medium size)Length Min. 230 min Width Min110+/-10 mm (for large size)	Length Min. 220 min Width Min80+/-10 mm (for small size)Length Min. 230 min Width Min95+/-10 mm (for medium size)Length Min. 230 min Width Min110+/-10 mm (for large 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(Water Tight -1000 ml) -ASTM D6319-19 (CrossReference D5151)	Passed	Passed	Same
Biocompatibility -SKIN SENSITIZATION -ISO 10993-10: 2010 (E)	Under the conditions of study not asensitizer	Under the conditions of studynot a sensitizer	Same
Biocompatibility -SKIN IRRITATION - ISO10993-10: 2010 (E)	Under the conditions ofthe study not an irritant	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
Biocompatibility -ACUTE SYSTEMICTOXICITY - ISO 10993-11: 2017(E)	Under the conditions ofthe study no systemic toxicity	No systemic toxicityunder the experimentalconditions employed	Similar
Manufacturer(s)	JIANGSU HEALTH-PEACEMEDICAL TECHNOLOGY CO.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:80 ± 10 mm (for small size)95 ± 10 mm (for medium size)110 ± 10 mm (for large size)Length: (Minimum)220 mm (for small size)230 mm (for medium, large size)Thickness: (Minimum)Finger -0.05 mm (for all sizes)Palm -0.05 mm (for all sizes)	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)	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	0.1mg/glove,Passed

BIO-COMPATIBILITY DATA

Test Method	Purpose	AcceptanceCriteria	Result
ISO 10993-10 Biological evaluationof medical devices — Part 10: Testsfor skin irritation and skinsensitization	To determine the potential of thematerial under test to produce skinirritation in rabbits	Under thecondition ofstudy not anirritant	Under the condition ofstudy not an irritant

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

ISO 10993-10 Biological evaluationof medical devices — Part 10: Testsfor skin irritation and skinsensitization	To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inguinea pigs.	Under theconditions of thestudy not asensitizer.	Under the conditions ofthe study not a sensitizer.
ISO 10993-5 Biological evaluation ofmedical devices — Part 5: Tests forin vitro cytotoxicity	To evaluate the in vitro cytotoxicpotential of the test item (bothinner and outer surface) Extractsin L-929 mouse fibroblasts cellsusing elution method	Under theconditions ofstudy, no morethan grade 2cytotoxicreaction	Mild (Grade 2)cytotoxicity reactionobserved.
ISO 10993-11:2017 Biologicalevaluation of medical devices—Part 11: Tests for acute systemictoxicity	The test item was evaluated foracute systemic toxicity in ICRMice	Under theconditions of thestudy no systemictoxicity	Under the conditions ofthe study no systemictoxicity

8. CLINICAL TESTING SUMMARY

Not applicable - Clinical data is not needed for gloves or for most devices 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 Gloves is 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.