Synguard Nitrile Exam 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.

Device Description

The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.

AI/ML Overview

The provided document describes the acceptance criteria and study results for the "Synguard Nitrile Exam Glove".

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319-19, ASTM D3767-03 (2020)	Physical Dimensions	Width: S: 84±5mm, M: 94±5mm, L: 110±5mm, XL: 120±5mmLength: S: 230mm, M: 230mm, L: 240mm, XL: 240mmThickness: Palm: 0.05mm min, Finger: 0.05mm min	Pass
ASTM D6319-19, ASTM D412-16	Physical Properties	Before Aging: Tensile Strength: 14MPa min, Ultimate Elongation: 500% minAfter Aging: Tensile Strength: 14MPa min, Ultimate Elongation: 400% min	Pass
ASTM D5151-19	Freedom from Holes	Be free from holes when tested in accordance with ASTM D5151	Pass
ASTM D6124-06	Powder free residue	Less than 2mg per glove	Pass
ISO 10993-10:2010	Irritation	The polar and nonpolar device extracts did not cause an irritation response in the animal model.	Pass
ISO 10993-10:2010	Sensitization	The polar and nonpolar device extracts did not cause a sensitizing response in the animal model.	Pass
ISO 10993-11:2009	Systemic Toxicity	The polar and nonpolar device extracts did not cause a systemic toxicity response in the animal model.	Pass

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for each specific test. However, it indicates that "non-clinical tests were conducted to verify that the performance of the proposed device met all design specifications of the applicable and current standards." These tests were likely conducted on samples of the Synguard Nitrile Exam Glove. The data provenance is implied to be from laboratory testing according to international standards (ASTM and ISO).

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

This information is not applicable. The tests performed are non-clinical, laboratory-based tests comparing physical and chemical properties to established industrial standards (ASTM, ISO), not involving human expert interpretation of results for ground truth.

4. Adjudication method for the test set

This information is not applicable as the tests are objective laboratory measurements against defined standards, not subjective interpretations requiring adjudication.

5. 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

This information is not applicable. The device is a medical examination glove, which does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable. The device is a medical examination glove, which is a physical product and does not involve algorithms or AI performance.

7. The type of ground truth used

The "ground truth" for the performance of the Synguard Nitrile Exam Glove is based on adherence to established international industrial standards and specifications. These include:

ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves
ASTM D3767-03 (2020): Standard Practice for Rubber-Measurement of Dimensions
ASTM D412-16: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves
ISO 10993-10:2010: Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11:2009: Biological evaluation of medical devices-Part 11: Tests for systemic toxicity

These standards define the acceptable ranges and performance criteria for the physical, chemical, and biological properties of examination gloves.

8. The sample size for the training set

This information is not applicable. As a physical medical device (examination glove), there is no 'training set' in the context of machine learning or AI models. The device's manufacturing processes and quality control procedures are engineered to meet the aforementioned standards.

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

This information is not applicable for the same reasons mentioned in point 8.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 12, 2022

Tianjin Aoshang Outdoor Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O.box 120-119 Shanghai. 200120 China

Re: K220442

Trade/Device Name: Synguard Nitrile Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 11, 2022 Received: February 16, 2022

Dear Diana Hong:

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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K220442

Device Name Synguard Nitrile Exam Glove

Indications for Use (Describe)

Synguard Nitrile Exam 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.

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K220442

1. Date of Preparation: 02/11/2022
1. Sponsor Identification

Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District, Tianjin

Contact Person: Xiaoning Zhang Position: QS Engineer Tel: +86-22-87702678 Fax: +86-22-87702677 Email: zhangning860222@163.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-2281-5850, Fax: 360-925-3199 Email: info@mid-link.net

4. Identification of Proposed Device

Trade Name: Synguard Nitrile Exam Glove Common Name: POWDER FREE NITRILE EXAMINATION GLOVES

Regulatory Information

Classification Name: polymer patient examination glove

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Classification: I; Product Code: LZA; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;

Indication for Use:

Synguard Nitrile Exam 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.

Device Description

ડ. Identification of Predicate Device
510(k) Number: K172015

Product Name: Powder Free Nitrile Examination Gloves, Blue (colored)

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6. Technological Characteristics Comparison

ITEM	Subject DeviceK220442	Predicate DeviceK172015	Comparison
Product Code	LZA	LZA	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
Indication for use	Synguard Nitrile Exam Glove is adisposable device intended formedical purposes that is worn on theexaminer's hand or finger to preventcontamination between patient andexaminer.	A patient examination glove is adisposable device intended formedical purposes that is worn on theexaminer's hand or finger to preventcontamination between patient andexaminer.	Same
Material	Acrylonitrile, Butadiene	Nitrile	Different
Color	Blue	Blue	Same
Sterility	Non-sterile	Non-sterile	Same
Single-use	Yes	Yes	Same
Size	S, M, L, XL	XS, S, M, L, XL
	Width
	/	XS	$70\pm10mm$
	S	$84\pm5mm$	$80\pm10mm$
	M	$94\pm5mm$	$95\pm10mm$
	L	$110\pm5mm$	$110\pm10mm$
	XL	$120\pm5mm$	$120\pm10mm$
	Length
Dimensions(ASTM D6319-19)	/	XS	220mm min	Different
	S	230mm	220mm min
	M	230mm	230mm min
	L	240mm	230mm min
	XL	240mm	230mm min
	Thickness
	Palm	0.05mm min	Palm	0.05mm min
	Finger	0.05mm min	Finger	0.05mm min
	Before Aging
Physical Properties(ASTM D6319-19and ASTMD412-16)	Tensile Strength	14MPa min	Tensile Strength	14MPa min	Same
	Ultimate Elongation	500% min	Ultimate Elongation	500% min
	After Aging
	Tensile Strength	14MPa min	Tensile Strength	14MPa min
	Ultimate Elongation	400% min	Ultimate Elongation	400% min
Power free residue(ASTM D6319-19and ASTMD6124-06)	Less than 2mg per glove		Less than 2mg per glove		Same
Freedom fromHoles (ASTMD5151-19)	No water leakage occurs.		Before aging: Meet AQL 1.5After aging: Meet AQL 2.5		Different
Biocompatibility
Skin Irritation	No Irritation		No Irritation
Sensitization	No Sensitization		No Sensitization		Different
Systemic Toxicity	No Toxicity		/

Table 1 Comparison of Technology Characteristics

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Different- Material

The material of the proposed device is different from predicate device.

Different- Size& Dimensions

The size and dimension of the proposed device is not exactly same as the predicate device.

Different- Freedom from Holes

The performance description of freedom from holes of the proposed device is different from predicate device.

Different- Biocompatibility

The biocompatibility test item of the proposed device is different from the predicate device.

7. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the performance of the proposed device met all design specifications of the applicable and current standards. The test results demonstrated that the proposed device complies with the following standards:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;

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ISO 10993-11:2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity; >

Test Methodology	Purpose	Acceptance Criteria		Results(Pass/Fail)
ASTM D6319-19,ASTM D3767-03(2020)	PhysicalDimensions	Width	S	84±5mm	Pass
			M	94±5mm
			L	110±5mm
			XL	120±5mm
		Length	S	230mm
			M	230mm
			L	240mm
			XL	240mm
		Thickness	Palm	0.05mm min
			Finger	0.05mm min
ASTM D6319-19,ASTM D412-16	Physical Properties	Before Aging	TensileStrength	14MPa min	Pass
			UltimateElongation	500% min
		After Aging	TensileStrength	14MPa min
			Ultimate	400% min

Table 2 Summary of non-clinical performance testing

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		Elongation
ASTM D5151-19	Freedom fromHoles	Be free from holes when tested in accordancewith ASTM D5151	Pass
ASTM D6124-06	Powder free residue	Less than 2mg per glove	Pass
ISO 10993-10:2010	Irritation	The polar and nonpolar device extracts did notcause an irritation response in the animalmodel.	Pass
ISO 10993-10:2010	Sensitization	The polar and nonpolar device extracts did notcause a sensitizing response in the animalmodel.	Pass
ISO 10993-11:2009	System toxicity	The polar and nonpolar device extracts did notcause a systemic toxicity response in theanimal model.	Pass

8. Clinical Test Conclusion

No clinical study is included in this submission.

9. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K172015.

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.