Nitrile Examination 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 Nitrile Examination Gloves. 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 document describes the acceptance criteria and study results for "Nitrile Examination Gloves" (K212551). The device is a non-sterile, powder-free, single-use patient examination glove made from nitrile compound.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
Physical Dimensions (ASMT D6319-19)	To determine the width, length, and thickness of the gloves	Width:80mm ±10mm (small)95mm ±10mm (medium)110 mm ±10mm (large)Length:220mm (Min) (small)230 mm (Min) (medium, large)Thickness:Finger - 0.05 mm (Min)Palm - 0.05 mm (Min)	Width:small size: 81 to 89mmmedium size: 91 to 98mmlarge size: 109 to 111mmLength:small size: 230mm (minimum)medium size: 240mm (minimum)large size: 244mm (minimum)Thickness:Finger: small size: 0.12mm (minimum), medium size: 0.13mm (minimum), large size: 0.13mm (minimum)Palm: small size: 0.08mm (minimum), medium size: 0.08mm (minimum), large size: 0.08mm (minimum)Result: Passed
Physical Requirements (ASMT D6319-19)	To determine 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): 26 (Minimum)Ultimate Elongation (%): 538 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 25 (Minimum)Ultimate Elongation (%): 511 (Minimum)Result: Passed
Freedom from Holes (ASTM D6319-19 (ASTM D5151-11))	To determine the holes in the gloves	AQL 2.5	Result: Passed
Residual Powder (ASMT D6319-19 (ASTM D6124-11))	To determine the residual powder in the gloves	< 2.0 mg/glove	0.4 mg/gloveResult: Passed
Skin Irritation (ISO 10993-10)	To determine the potential of the material to produce skin irritation in rabbits	Under the condition of study, testing articles are not an irritant	Under the conditions of the study the sample did not induce skin irritation.Result: Compliant
Skin Sensitization (ISO 10993-10)	To determine the skin sensitization potential of the material in guinea pigs	Under the conditions of the study, the testing articles are not a sensitizer.	Under the conditions of study, the test article did not show significant evidence of causing skin sensitization in the guinea pig.Result: Compliant
In Vitro Cytotoxicity (ISO 10993-5)	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.Result: Compliant (with criterion for no more than Grade 2)

2. Sample sizes for the test set and data provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for physical dimensions, tensile strength, or freedom from holes). Instead, it refers to industry standards (ASTM and ISO). These standards typically specify sampling plans.
The data provenance is not explicitly mentioned (e.g., country of origin for the testing). The submission is made by "Anhui Fine Glove Medical Technology Co., Ltd" which implies the manufacturing and potentially some testing occurred in China (CN 233100 listed). The correspondent is from Australia. The tests themselves refer to international standards.
The studies were non-clinical (laboratory-based performance and biocompatibility testing), not based on patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This is not applicable as the studies were non-clinical performance and biocompatibility tests conducted in a laboratory setting against defined technical standards (ASTM, ISO). There was no "ground truth" established by experts in the context of clinical interpretation or diagnosis.

4. Adjudication method for the test set:

This is not applicable to non-clinical performance and biocompatibility testing against defined technical standards. Test results are objective measurements compared against numerical or qualitative criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images. The device in question is a medical glove.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. The device is a physical medical glove and does not involve an AI algorithm. The performance evaluation is based on the physical and chemical properties of the glove itself.

7. The type of ground truth used:

The "ground truth" for the test set in this context refers to the established technical specifications and criteria defined in the referenced standards: ASTM D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993-10, and ISO 10993-5. These standards provide the objective benchmarks for evaluating the glove's performance.

8. The sample size for the training set:

This is not applicable. The device is a physical product (medical glove) and does not involve an AI model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable, as there is no training set for this type of device.

Summary

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November 5, 2021

Anhui Fine Glove Medical Technology Co., Ltd Johnson Liu Official Correspondent CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia

Re: K212551

Trade/Device Name: 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: August 9, 2021 Received: August 13, 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.

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 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, 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K212551

Device Name Nitrile Examination Gloves

Indications for Use (Describe)

Nitrile Examination 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)

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510(K) Summary

Nitrile Examination Gloves

Preparation Date: Nov 6th, 2021

1. SUBMITTER

Company Name: ANHUI FINE GLOVE MEDICAL TECHNOLOGY CO., LT Company Address: Intersection of Feng Xiang Avenue and Gong Ye Road Chu Zhou Anhui, CN 233100 Contact Person: Johnson Liu Telephone Number: +614-0158-9995 Email: Johnson@cnmed.com.au

2. NAME OF THE DEVICE

Trade Name / Proprietary Name: Nitrile Examination 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. INDICATIONS FOR USE OF THE DEVICE

Nitrile Examination Gloves are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES

CHARACTERISTICS	DEVICE PERFORMANCE		REMARKS
	SUBJECT	PREDICATE
510(k) Number	K212551	K203191	-
Device Name	Nitrile Examination Gloves	LYDUS Nitrile Examination Gloves, Powder Free	-
Product Code	LZA	LZA	Same
Indications for Use	Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the-counter use.	LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and 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 Ultimate Elongation Min 500%After AgingTensile StrengthMin 14 Mpa Ultimate Elongation 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)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, mildcytotoxicity (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)	Not Tested	No systemic toxicityunder the experimentalconditions employed	Different¹
Manufacturer(s)	ANHUI FINE GLOVEMEDICAL TECHNOLOGY CO.,LTD	Nathan Trading Co., Ltd	-----

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1 Justification: Based on the intended use of the subject device, the Biocompatibility- acute systemic toxicity testing was not required as per ISO 10993-1.

Conclusion:

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

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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:220mm (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 size81 to 89mmmedium size91 to 98mmlarge size109 to 111mmLengthsmall size230mm (minimum)medium size240mm (minimum)large size244mm (minimum)ThicknessFingersmall size0.12mm (minimum)medium size0.13mm (minimum)large size0.13mm (minimum)Palmsmall size0.08mm (minimum)medium size0.08mm (minimum)large size0.08mm (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):26 (Minimum)Ultimate Elongation (%):538 (Minimum)After Acceleration Aging:Tensile Strength (MPa):25 (Minimum)Ultimate Elongation (%):511 (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	0.4 mg/glove, Passed

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BIO-COMPATIBILITY DATA

Test Method	Purpose	Acceptance Criteria	Result
ISO 10993-10 Biologicalevaluation of medicaldevices — Part 10: Tests forskin irritation and skinsensitization	To determine the potentialof the material under testto produce skin irritation inrabbits	Under the condition ofstudy, testing articles arenot an irritant	Under the conditions ofstudy, the test article did notshow significant evidence ofcausing skin sensitization inthe guinea pig.
ISO 10993-10 Biologicalevaluation of medicaldevices — Part 10: Tests forskin irritation and skinsensitization	To determine the skinsensitization potential ofthe material both in termsof induction and elicitationin guinea pigs.	Under the conditions ofthe study, the testingarticles are not asensitizer.	Under the conditions ofthe study the sample did notinduce skin irritation.
ISO 10993-5 Biologicalevaluation of medicaldevices — Part 5: Tests forin vitro cytotoxicity	To evaluate the in vitrocytotoxic potential of thetest item (both inner andouter surface) Extracts in L-929 mouse fibroblasts cellsusing elution method	Under the conditions ofstudy, no more than grade2 cytotoxic reaction	Mild (Grade 2) cytotoxicityreaction observed.

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 Nitrile Examination 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.