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

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for Disposable Nitrile Gloves (K210276). It is not for an AI/ML medical device, but rather for a physical medical device (gloves). Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this document.

The document discusses the substantial equivalence of the Disposable Nitrile Gloves to a predicate device (K171422) based on performance testing and adherence to recognized standards.

Here's an attempt to interpret the provided content in the context of your request, while acknowledging that it doesn't fit the typical AI/ML device evaluation structure:

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

The document outlines comparisons between the subject device (K210276) and the predicate device (K171422), effectively serving as the acceptance criteria for substantial equivalence. The reported device performance is demonstrated by its compliance with the listed standards.

Acceptance Criteria (Common to Subject & Predicate)	Reported Device Performance (K210276)
General Characteristics
Product Code: LZA	LZA
Regulation No: 21CFR880.6250	21CFR880.6250
Class: I	I
Intended Use: Medical purposes; worn on examiner's hands to prevent contamination between patient and examiner.	Same
Powdered/Powered free: Powdered free	Powdered free
Design Feature: Ambidextrous	Ambidextrous
Labeling Information: Single-use indication, powder free, device color, device name, glove size and quantity	Single-use indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Blue, Non-Sterile
Dimensions (Compliance with ASTM D6319-19)
Length, mm: 230 min (for predicate)	230 mm (S, M, L, XL) with ±10 tolerance
Width, mm: 75, 85, 95, 105, 115 (for predicate) with ±5 tolerance	85 (S), 95 (M), 110 (L), 115 (XL) with ±10 tolerance
Thickness, mm: Finger 0.05 min	0.05 min
Thickness, mm: Palm 0.05 min	0.05 min
Physical Properties
Before Aging: Tensile Strength 14MPa, min	14MPa, min
Before Aging: Ultimate Elongation 500% min	500% min
After Aging: Tensile Strength 14MPa, min	14MPa, min
After Aging: Ultimate Elongation 400%min	400%min
Freedom from Holes: Comply with ASTM D6319, be free from holes when tested in accordance with ASTM D5151 AQL=2.5	Comply with ASTM D6319, be free from holes when tested in accordance with ASTM D5151 AQL=2.5
Powder Content: Meet requirements of ASTM D6124	0.01 mg per glove
Safety/Biocompatibility (Compliance with ISO 10993)
Material: Nitrile	Nitrile
Irritation: Not an irritant (comply with ISO10993-10)	Not an irritant (under the conditions of the study)
Sensitization: Not a sensitizer (comply with ISO10993-10)	Not a sensitizer (under conditions of the study)
Cytotoxicity: Device extract is not cytotoxic (comply with ISO10993-5)	Device extract is not cytotoxic (under conditions of the study)

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

Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., number of gloves tested for tensile strength, holes, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The standards themselves (e.g., ASTM D6319, ASTM D5151) would define the required sample sizes for their respective tests, but these details are not present in this summary.
Data Provenance: The tests were non-clinical performance tests, usually performed in a lab setting by the manufacturer or a contracted lab. The manufacturer is Fujian Ercon Medical Management Co., Ltd. in China. The provenance is internal testing, not patient data.

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

Not Applicable. This is not a study requiring expert readers or ground truth establishment in the context of interpreting medical images or data. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., a hole is present or absent according to ASTM D5151 criteria).

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

Not Applicable. As this is not an interpretive/diagnostic study, no adjudication method for human readers is relevant. The tests are laboratory measurements.

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/ML diagnostic aid. There were no human readers or AI assistance involved.

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

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

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

The "ground truth" for this device's performance is objective measurements and compliance with industry standards (e.g., ASTM D6319-19 for glove specifications, ASTM D5151-19 for holes, ISO 10993 for biocompatibility). It is based on pre-defined engineering specifications and test protocols.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device; there is no training set.

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

In summary, the provided document details the regulatory submission for a physical medical device, not an AI/ML diagnostic tool. Therefore, many of the questions related to AI/ML study design are not applicable. The device's acceptance is based on non-clinical performance testing confirming its compliance with recognized standards and substantial equivalence to a legally marketed predicate device.

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 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.

April 16, 2021

Fujian Ercon Medical Management Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210276

Trade/Device Name: Disposable Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 20, 2021 Received: February 1, 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.

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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 (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) K210276

Device Name Disposable Nitrile Gloves

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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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 (K210276)

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

1.0 Submitter's Information

Name: FUJIAN ERCON MEDICAL MANAGEMENT CO., LTD. Address: Unit 701, Xinyi International Center, No.3911 Huandao East Road, Siming District, Xiamen City, Fujian Province, China 361000. Tell: +86- 592-5721376 Contact: Lin Ruijin Date of Preparation: Apr. 10,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Disposable Nitrile Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove S,M,L,XL Model(s):

3.0 Classification

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

4.0 Predicate Device Information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Disposable Powder Free Nitrile Examination Glove, White/ Device:

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Blue/ Black/ Pink Color 510(k) number: K171422

5.0 Indication for Use

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

6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

Table1-General Comparison
Item	Subject Device(K210276)	Predicated Device(K171422)	Remark
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The DisposableNitrile Gloves areintended formedical purposesthat is worn on theexaminer's handsto preventcontaminationbetween patientand examiner.	The DisposablePowder Free NitrileExamination Glove,White/ Blue/ Black/Pink Color is adisposable deviceintended formedical purposesthat is worn on theexaminer's handsto preventcontaminationbetween patientand examiner.	Same
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Labeling Information	Single-useindication, powderfree, device color,device name,glove size and	Single-useindication, powderfree, device color,device name, glovesize and quantity	Same

Table1-General Comparison

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	quantity, NitrileGlove PowderFree Blue, Non-Sterile	Disposable PowderFree NitrileExamination Glove,Non-Sterile
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Table2 Device Dimensions Comparison

PredicateDevice(K171422)	Designation	Size				Tolerance
		XS	S	M	L	XL
	Length, mm	230	230	230	230	230	min
	Width, mm	75	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
SubjectDevice(K210276)	Designation	Size				Tolerance
		S	M	L	XL
	Length, mm	230	230	230	230	±10
	Width, mm	85	95	110	115	±10
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
Remark	Similar

Analysis: The tolerance of length is different with that 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		Subject device(K210276)	Predicated device(K171422)	Remark
Colorant		Blue	White/ Blue/ Black/ Pink	Same
PhysicalProperties	BeforeAging	Tensile Strength14MPa, min	14MPa, min	Same
		Ultimate Elongation500% min	500% min	Same
	AfterAging	Tensile Strength14MPa, min	14MPa, min	Same
		Ultimate Elongation400%min	400%min	Same
Freedom from Holes		Comply with ASTM D6319	Comply with ASTMD6319	Same
		Be free from	Be free from	Same

Table3 Performance Comparison

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	holes whentested inaccordance withASTMD5151AQL=2.5	holes whentested inaccordance withASTMD5151AQL=2.5
Powder Content	$0.01 \text{ mg per glove}$	Meet therequirementsof ASTMD6124	Same

Table4 Safety Comparison

Table4 Safety Comparison
Item	Subjectdevice(K210276)	Predicateddevice(K171422)	Remark
	Material	Nitrile		Nitrile
Biocompatibility	Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization)	Under theconditions ofthe study, notan irritant	Comply withISO10993-10	Same
	Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization)	Underconditions ofthe study, nota sensitizer.
	Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity)	Underconditions ofthe study,deviceextract is notcytotoxic	/	Similar

8.0 Discussion of Non-clinical and Performance Testing

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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.

9.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Nitrile Gloves ,is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K171422.

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.