Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device is a power free medical glove. The device is provided in blue and black. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, 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

This document is a 510(k) Summary for Nitrile Exam Gloves (Blue, Black) by Hebei Astro Medical Supply Co., Ltd. It compares the proposed device to a predicate device (K211457) and presents non-clinical test results to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document provides a comprehensive table summarizing the performance testing and biocompatibility testing.

Table of Acceptance Criteria and Reported Device Performance

Name of Test Methodology/Standard	Acceptance Criteria	Reported Device Performance
Performance Testing
ASTM D5151-19 (Freedom from Holes)	Gloves are free from water droplets, stream, or other types of water leakage (AQL 2.5 with G1)	Requirement met
ASTM D3767-03 (2020) (Dimensions)	Conform to minimum values: - Width (XS: 75±5mm, S: 85±5mm, M: 95±5mm, L: 105±5mm, XL: 115±5mm, XXL: 125±5mm) - Length: 230mm min - Thickness (Palm: 0.05mm min, Finger: 0.05mm min)	Requirement met
ASTM D412-16 (Physical Properties)	Before Aging: - Tensile Strength: 14MPa min - Ultimate Elongation: 500% min After Aging: - Tensile Strength: 14MPa min - Ultimate Elongation: 400% min	Requirement met
ASTM D6124-06 (Residual Powder)	Less than 2mg per glove	Requirement met
Biocompatibility Testing
ISO 10993-11:2017 (System Toxicity)	Non-system toxicity	Non-system toxicity
ISO 10993-10:2010 (Sensitization)	Non-sensitizing	Non-sensitizing
ISO 10993-10:2010 (Intracutaneous Reactivity)	Non-irritating	Non-irritating

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not explicitly state the sample sizes used for each specific test within the non-clinical evaluations. The ASTM and ISO standards generally specify sample size requirements, but the report summarizes the results as "Requirement met" or provides a qualitative result without detailing the number of units tested.
Data Provenance: The tests were conducted by a medical device manufacturer in China (Hebei Astro Medical Supply Co., Ltd.). The data would be considered prospective as it was generated specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the described tests are for physical and chemical properties of a medical glove and biocompatibility. These types of tests do not involve human interpretation or subjective 'ground truth' establishment by experts in the context of medical image analysis or similar diagnostic studies. The "ground truth" here is determined by objective measurements and standardized laboratory procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None. Adjudication methods are typically employed in studies involving human interpretation (e.g., radiologists reviewing images) where there might be disagreement in assessments. The tests described for these nitrile exam gloves are objective, laboratory-based physical, chemical, and biological evaluations that yield measurable results against predefined criteria.

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

Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This device is a physical medical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on objective measurements and standardized laboratory test methods defined by recognized international and national standards (ASTM and ISO). For example:

Physical Properties: Measured values (tensile strength, elongation, dimensions, powder residue) compared against specified numerical limits in ASTM standards.
Freedom from Holes: Visual inspection or other methods against a defined AQL (Acceptable Quality Limit).
Biocompatibility: Observation of biological responses (e.g., skin sensitization, irritation, systemic toxicity) in animal models or in vitro tests against criteria established in ISO standards for acceptable biological reactions.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product where performance is evaluated through standardized non-clinical testing.

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

Not applicable. As stated above, there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

August 25, 2022

Hebei Astro Medical Supply Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O.box 120-119 Shanghai. 200120 China

Re: K221143

Trade/Device Name: Nitrile Exam Gloves (Blue, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 25, 2022 Received: July 25, 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); medical device reporting (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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, 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 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) K221143

Device Name

Nitrile Exam Gloves (Blue, Black)

Indications for Use (Describe)

Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is 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

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

The assigned 510(k) Number: K221143

1. Date of Preparation: 8/23/2022
1. Sponsor Identification

Hebei Astro Medical Supply Co., Ltd.

Address: East of Xiaoxixian, West of Jingsan Street, South of Weiwu Road, North of Weigi Road,

Jinzhou Economic Development Zone, Hebei Province, P.R, China, 052260

Establishment Registration Number: 3015537296

Contact Person: Ning Zheng

Position: General Manager

Tel: +86-311-85125369

Email: erin@wallyplastic.net

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person)

Ms. Jinlei Tang (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

1. Identification of Proposed Device
  Trade Name: Nitrile Exam Gloves (Blue, Black)

Common Name: POWDER FREE NITRILE EXAMINATION GLOVES

Regulatory Information

Classification Name: polymer patient examination glove

Classification: I;

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

Indication for Use:

Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

1. Identification of Predicate Device
  510(k) Number: K211457 Product Name: Powder Free Nitrile Examination Gloves, (Blue, Black, Indigo)
1. Summary of Technological characteristics

ITEM	Proposed Device	Predicate Device K211457	Comparison
Product Code	LZA	LZA	Same
RegulationNumber	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
Indication for use	Nitrile Exam Gloves(Blue, Black) is adisposable device intendedfor medical purpose that isworn on the examiner's handsto prevent contaminationbetween patient and examiner.	The Powder Free NitrileExamination Gloves is adisposable device intended formedical purpose that is worn onthe examiner's hands to preventcontamination between patientand examiner.	Same
Material	Nitrile	Nitrile	Same
Color	Blue, Black	Blue, Black, Indigo	Different
Sterility	Non-sterile	Non-sterile	Same
Single-use	Yes	Yes	Same
Surface Treatment/Powder orPowder Free	Powder Free	Powder Free	Same

Table 1 Comparison of Technology Characteristics

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Size	XS, S, M, L, XL, XXL		XS, S, M, L, XL		Different
	Width
	XS	75±5mm	XS	70±10mm
	S	85±5mm	S	80±10mm
	M	95±5mm	M	95±10mm
	L	105±5mm	L	110±10mm
	XL	115±5mm	XL	120±10mm
	XXL	125±5mm	/	/
	Length
Dimensions(ASTM D6319-19)	XS	230mm min	XS	230mm min
	S	230mm min	S	230mm min
	M	230mm min	M	230mm min
	L	230mm min	L	230mm min
	XL	230mm min	XL	230mm min
	XXL	230mm min	/	/
	Thickness
	Palm	0.05mm min	Palm	0.08-0.10 mm
	Finger	0.05mm min	Finger	0.10-0.12 mm
	Before Aging
PhysicalProperties(ASTM D6319-19 andASTM D412-16)	Tensile Strength	14MPa min	Tensile Strength	14MPa min	Same
	UltimateElongation	500% min	UltimateElongation	500% min

	After Aging
	Tensile Strength	14MPa min	Tensile Strength	14MPa min
	UltimateElongation	400% min	UltimateElongation	400% min

Powerfreeresidue(ASTM D6319-19 andASTM D6124-17)	Less than 2mg per glove		Less than 2mg per glove		Same


FreedomfromHoles(ASTM D5151-19)	Meet AQL 2.5 with G1		Meet AQL 1.5 with G1		Different

Biocompatibility
Sensitization	Under the conditions of study, nota sensitizer		Under the conditions of study, not asensitizer		Different
IntracutaneousReactivity	Under the conditions of study, notan irritant		Under the conditions of study, notan irritant
System Toxicity	Under the conditions of study,non-system toxicity		Not tested
In Vitro Cytotoxicity	Not tested		Under the conditions of study,
			non-system toxicity

Different - Color

The proposed device is provided in two colors, blue and black, and the predicate device is provided

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in three colors, blue, black and indigo. The color of the proposed device can be covered by the predicate device.

Different - Size & Dimensions

The size and dimension of the proposed device is not exactly same as the predicate device. The user can select appropriate model depended on size of user's hand.

Different - Freedom from Holes

The freedom from holes of the proposed device is different from predicate device. The proposed device meets AQL 2.5 with G1, while the predicate device meets AQL 1.5 with G1.

Different - Biocompatibility

The biocompatibility test item of the proposed device is different from the predicate device. The proposed device was conducted for systemic toxicity and not for cytotoxicity. While the predicate device was conducted for cytotoxicity and not for systemic toxicity.

1. Summary of Non-Clinical Test
  Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the Nitrile Exam Gloves (Blue, Black) 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:
ISO 10993-11:2017 Biological evaluation of medical devices-Part 11: Tests for systemic

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toxicity;

Name of the TestMethodology/Standard	Purpose	Acceptance Criteria	Results
ASTM D5151-19Standard TestMethod forDetection of Holes inMedical Gloves	The test wasperformed inaccordance withASTM D5151-19Standard TestMethod forDetection of Holes inMedical Gloves toevaluate thedetection of holes inmedical gloves.	Gloves are free from water droplets,stream, or other types of waterleakage.	Requirementmet
ASTM D3767-03(2020) StandardPractice for Rubber –Measurement ofDimensions	The test wasperformed inaccordance withASTM D3767-03(2020) StandardPractice for Rubber –Measurement ofDimensions toevaluate thegeometricaldimension of rubberproducts andspecimens forphysical tests.	The measurement results shallconform to the minimum valuesspecified in the table below.	Requirementmet
Width
		XS75±5mm
		S85±5mm
		M95±5mm
		L105±5mm
		XL115±5mm
		XXL125±5mm
		Length230mm min
		Thickness
		Palm0.05mm min
		Finger0.05mm min
ASTM D412-16Standard TestMethods forVulcanized Rubberand ThermoplasticElastomers—Tension	The test wasperformed inaccordance withASTM D412-16Standard TestMethods forVulcanized Rubberand ThermoplasticElastomers—Tensionto evaluate the	The measurement results shallconform to the minimum valuesspecified in the table belowBefore Aging:TensileStrength14MPa minUltimateElongation500% minAfter Aging:	Requirementmet
	tensile (tension)propertiesofvulcanized thermosetrubbers andthermoplasticelastomers.	TensileStrength	14MPa min
		UltimateElongation	400% min
ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves	The test wasperformed inaccordance withASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves to evaluatethe amount ofresidual powder (orfilter- retained mass)found on medicalgloves.	Less than 2mg per glove	Requirementmet

Table 2 Summary of Performance Testing

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Table 3 Summary of Biocompatibility Testing

Test Methodology	Purpose	Acceptance Criteria	Result
System Toxicity	Thetestwasperformedinaccordance with ISO10993-11Biologicalevaluation of medicaldevices - Part 11:Tests for systemictoxicity to evaluate thesystemic toxicity ofthe test sample.	Non-system toxicity	Under the conditionsofthestudy,theproposed device wasnon-system toxicity.
Sensitization	Thetestwasperformedinaccordance with ISO10993-10ThirdEdition2010-08-01Biological evaluationof medical devices -Part 10:Tests forirritationandskinsensitizationtoevaluatethe	Non-sensitizing	Under the conditionsofthestudy,theproposed device wasnon-sensitizing.

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	sensitization of the test sample.
IntracutaneousReactivity	The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization to evaluate the irritation of the test sample.	Non-irritating	Under the conditions of the study, the proposed device was non-irritating.

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 K211457.

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.