The Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

AI/ML Overview

This is a 510(k) premarket notification for Nitrile Examination Gloves, a Class I reserved medical device. The submission aims to demonstrate substantial equivalence to a predicate device (K171422). The "acceptance criteria" in this context refers to the performance standards and test results that the new device must meet to be considered substantially equivalent to the predicate device and safe/effective for its intended use.

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

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

The provided tables (Table2 Device Dimensions Comparison, Table3 Performance Comparison, and Table4 Safety Comparison) effectively serve as a comparison of the proposed device's performance against the predicate device, which inherently defines the "acceptance criteria" for substantial equivalence.

Acceptance Criteria Category	Specific Criteria (from ASTM standards & Predicate)	Proposed Device Performance	Remark/Conclusion on Meeting Criteria
Dimensions	Length (mm):
	XS: 230 min (Predicate)	220 min	Analysis 1: Meets ASTM D6319-19
	S: 230 min (Predicate)	220 min	Analysis 1: Meets ASTM D6319-19
	M: 230 min (Predicate)	230 min	Meets Predicate & ASTM D6319-19
	L: 230 min (Predicate)	230 min	Meets Predicate & ASTM D6319-19
	XL: 230 min (Predicate)	230 min	Meets Predicate & ASTM D6319-19
	Width (mm):
	XS: 75 ±5 (Predicate)	70 ±10	Analysis 1: Meets ASTM D6319-19
	S: 85 ±5 (Predicate)	80 ±10	Analysis 1: Meets ASTM D6319-19
	M: 95 ±5 (Predicate)	95 ±10	Meets Predicate & ASTM D6319-19
	L: 105 ±5 (Predicate)	110 ±10	Analysis 1: Meets ASTM D6319-19
	XL: 115 ±5 (Predicate)	120 ±10	Analysis 1: Meets ASTM D6319-19
	Thickness (mm):
	Finger: 0.05 min (Predicate)	0.05 min	SAME (Meets Predicate)
	Palm: 0.05 min (Predicate)	0.05 min	SAME (Meets Predicate)
Physical Properties	Before Aging:
	Tensile Strength: 14MPa, min (ASTM D6319)	14MPa, min	SAME (Meets ASTM D6319)
	Ultimate Elongation: 500% min (ASTM D6319)	500% min	SAME (Meets ASTM D6319)
	After Aging:
	Tensile Strength: 14MPa, min (ASTM D6319)	14MPa, min	SAME (Meets ASTM D6319)
	Ultimate Elongation: 400% min (ASTM D6319)	400% min	SAME (Meets ASTM D6319)
	Overall Compliance with ASTM D6319	Comply with ASTM D6319	SAME (Meets ASTM D6319)
Freedom from Holes	Be free from holes in accordance with ASTMD5151 AQL=2.5	Be free from holes in accordance with ASTMD5151 AQL=2.5	SAME (Meets ASTM D5151)
Powder Content	Meet the requirements of ASTM D6124 (Predicate)	0.1 (meets ASTM D6124)	SIMILAR (Meets ASTM D6124)
Biocompatibility	Irritation: Complies with ISO 10993-10	Not an irritant	SAME (Meets ISO 10993-10)
	Sensitization: Complies with ISO 10993-10	Not a sensitizer	SAME (Meets ISO 10993-10)
	Cytotoxicity: Complies with ISO 10993-5	Did not show potential toxicity to L-929 cells	SIMILAR (Meets ISO 10993-5)
Material	Nitrile	Nitrile	SAME
Label and Labeling	Meet FDA's Requirement	Meet FDA's Requirement	SAME
Colorant	White/Blue/Black/Pink (Predicate)	Blue	Analysis 2: Biocompatibility test confirms safety
Expiration Dating	ASTM D7160-16 for medical gloves	Not explicitly stated in tables, but implies compliance in Non-Clinical Tests section.	Assumed to be met via D7160-16.

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

Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for Freedom from Holes, Tensile Strength, etc.). It only references compliance with ASTM standards, which would define appropriate sample sizes for those tests.
Data Provenance: The tests are non-clinical (laboratory tests). The manufacturing location is China (5R MED Instruments (Chengdu) Co., Ltd.). The tests themselves are performed according to international (ISO) and U.S. (ASTM) standards. These are prospective tests, specifically conducted to demonstrate compliance for this device submission.

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

This device is not an AI/software device that requires human expert adjudication for ground truth. The "ground truth" for Nitrile Examination Gloves is established by objective, standardized physical and chemical tests defined by international (ISO) and U.S. (ASTM) consensus standards. Therefore, human experts for ground truth establishment in the clinical sense are not applicable here. The experts involved would be the certified laboratory technicians and engineers performing and interpreting the results of the specified standards.

4. Adjudication method for the test set:

Not applicable. As noted above, this device relies on objective, quantifiable physical and chemical tests, 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:

Not applicable. This is a physical medical device (gloves), not an AI-powered diagnostic or assistance tool.

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

Not applicable. This is a physical medical device (gloves).

7. The type of ground truth used:

The ground truth is established by objective, standardized tests defined by ASTM and ISO standards. These standards provide quantifiable criteria for properties like dimensions, tensile strength, elongation, freedom from holes, powder content, and biocompatibility.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning device that requires a training set.

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

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

In summary, the "study" proving the device meets acceptance criteria consists of a series of non-clinical, laboratory-based tests conducted in accordance with recognized industry standards (ASTM D6124, ASTM D5151, ASTM D6319, ASTM D7160, ISO 10993-10, ISO 10993-5). The acceptance criteria are essentially the performance requirements set forth in these standards and demonstrated by the predicate device. The results of these tests (summarized in the tables) indicate that the proposed device performs comparably to the predicate and meets the relevant safety and performance standards.

Summary

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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

July 12, 2021

5R MED Instruments (Chengdu) Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210776

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: June 9, 2021 Received: June 16, 2021

Dear Boyle Wang:

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,

Ryan Ortega, PhD Acting 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

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Indications for Use

510(k) Number (if known) K210776

Device Name Nitrile Examination Gloves

Indications for Use (Describe)

The Nitrile Examination Gloves are disposable devices intended for medical purposes that are 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 K210776

This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.

1.0 submitter's information

Name: 5R MED Instruments (CHENGDU) Co., Ltd. Address: Building 9, Section 1, No.618 of West Kelin Road, Chengdu Cross-Straits Technology Industry Development Zone, Wenjiang District, Chengdu, Sichuan Province, 611130, China Phone Number: +86-13928606563 Contact: Yuzhanq Pan Date of Preparation: 2021.03.02

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device information

Trade name: Nitrile Examination Gloves

Common name: Patient Examination Gloves

Classification name: Non-powdered patient examination glove

Model(s): XS, S, M, L, XL 3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I General Hospital Panel:

4.0 Predicate device information

Ever Global (Vietnam) Enterprise Corp Manufacturer:

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Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422

5.0 Indications for use

The Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

6.0 Device description

7.0 Summary comparing technological characteristics with predicate device

Item	Proposed device	Predicated device	Remark
510(k) number	K210776	K171422	Same
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Indications for use	The Nitrile ExaminationGloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	The Disposable PowderFree Nitrile ExaminationGlove, White/ Blue/ Black/Pink Color is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	Same
Powdered or Powered free	Powdered free	Powdered free	Same
Design Feature	ambidextrous	ambidextrous	Same
Labeling Information	Single-use indication,powder free, device color,device name, glove sizeand quantity, NitrileExamination Gloves,Non-Sterile	Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove,	Same

Table1-General Comparison

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			Non-Sterile
--	--	--	-------------	--

PredicateDevice(K171422)	Designation	Size					Tolerance
	Length, mm	XS	S	M	L	XL
		230	230	230	230	230	min
	Width, mm	75	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
Proposed Device	Designation	Size					Tolerance
		XS	S	M	L	XL
	Length, mm	220	220	230	230	230	min
	Width, mm	70	80	95	110	120	±10
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
Remark		Analysis 1

Table2 Device Dimensions Comparison

Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Item			Proposed device	Predicated device	Remark
Colorant			blue	White/ Blue/ Black/ Pink	Analysis2
PhysicalProperties	BeforeAging	TensileStrength	14MPa, min	14MPa, min	SAME
		UltimateElongation	500%min	500%min	SAME
	AfterAging	TensileStrength	14MPa, min	14MPa, min	SAME
		UltimateElongation	400%min	400%min	SAME
	Comply with ASTM D6319		Comply with ASTM D6319		SAME
Freedom from Holes			Be free from holes when tested in accordance with ASTMD5151 AQL=2.5	Be free from holes when tested in accordance with ASTMD5151 AQL=2.5	SAME
Powder Content			0.1	Meet the requirements of ASTM D6124	SIMILAR

Table3 Performance Comparison

Analysis2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect the safety of proposed device.

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Item		Proposed device	Predicated device	Remark
Material		Nitrile	Nitrile	SAME
Biocompatibility	Irritation	Under the conditions of the study, not an irritant	Comply with ISO10993-10	SAME
	Sensitization	Under conditions of the study, not a sensitizer.
	Cytotoxicity	Under conditions of the study, did not show potential toxicity to L-929 cells.	Comply with ISO10993-5	SIMILAR
Label and Labeling		Meet FDA's Requirement	Meet FDA's Requirement	SAME

Table4 Safety Comparison

8.0 Discussion of non-clinical and clinical test performed

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

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19,Standard Specification For Nitrile Examination Gloves For Medical Application.

ASTM D7160-16,Standard Practice for Determination of Expiration Dating for Medical Gloves

Clinical testing is not needed for this device.

9.0 Conclusion

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

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.