The Disposable nitrile 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 Disposable nitrile 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

The provided document describes the non-clinical performance testing for "Disposable Nitrile Gloves" (K212009) to demonstrate substantial equivalence to a predicate device (K171422).

Here's the breakdown of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|-----|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin sensitization. | Grades less than 1, otherwise sensitization. | All grades are 0. All animals survived and no abnormal signs were observed. |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin irritation. | Primary irritation index of 0-0.4 for negligence. | Primary irritation index is 0. The response of the proposed device was categorized as negligible. |
| 3 | ISO 10993-5:2009 (Cytotoxicity) | Assesses the in vitro cytotoxicity of medical devices. | Viability percentage (Viab.%) of the 100% extract of the test article is the final result. If viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 71.75%. This means the proposed device has no potential toxicity to L-929 in the MTT method. |
| 4 | ASTM D6124-06 (Reapproved 2017) (Residual Powder on Medical Gloves) | Designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves. | Powder residue limit of 2.0 mg/glove. | 0.06 mg/glove. |
| 5 | ASTM D5151-06 (Reapproved 2015) (Detection of Holes) | Covers the detection of holes in medical gloves. | Sample number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤ 7 gloves for water leakage. | No glove water leakage found. |
| 6 | ASTM D6319-10 (Reapproved 2015) (Nitrile Examination Gloves) | Covers certain requirements for nitrile rubber gloves used in medical examinations and diagnostic and therapeutic procedures. | Freedom from holes: Refer to No. 5. Dimensions: S: width 80±10mm, Length ≥220 mm; M: width 95±10mm, Length ≥230 mm; L: width 110±10mm, Length ≥230 mm; XL: width 120±10mm, Length ≥230 mm. Thickness: Finger ≥0.05 mm, Palm ≥0.05 mm. Physical properties (Before Aging): Tensile strength ≥14MPa, Ultimate Elongation ≥500%. Physical properties (After Accelerated Aging): Tensile strength ≥14MPa, Ultimate Elongation ≥400%. | Dimensions: S: width: 82-86 mm, Length 238-245 mm; M: width 97-99 mm, Length 243-249 mm; L: width 108-111 mm, Length 244-254 mm; XL: width 115-118 mm, Length 237-246 mm. Thickness: Finger 0.13-0.15 mm, Palm 0.08 mm. Physical properties (Before Aging): Tensile strength 14.12-22.10 MPa, Ultimate Elongation 537.05%-907.44%. Physical properties (After Accelerated Aging): Tensile strength 14.46-20.20 MPa, Ultimate Elongation 542.91%-856.03%. |

2. Sample Size Used for the Test Set and Data Provenance

Sample Sizes:
- Skin Sensitization, Skin Irritation, and Cytotoxicity: The document states "All grades are 0. All animals were survived and no abnormal signs were observed during the study." for sensitization, and "The primary irritation index is 0." for irritation, and "Viab.% of 100% test article extract is 71.75%" for cytotoxicity. While it indicates successful testing, the specific numerical sample size for these biological evaluation tests (e.g., number of animals or cell cultures) is not explicitly provided in the summary.
- Freedom from Holes (ASTM D5151-06): 125 gloves.
- Residual Powder (ASTM D6124-06): Not specified, but implied to be sufficient for a quantitative measurement (0.06 mg/glove).
- Dimensions and Physical Properties (ASTM D6319-10): Specific sample sizes for each dimension, thickness, and physical property measurement are not provided in this summary, but the results for ranges are given.
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that this is a 510(k) summary for a Chinese manufacturer (JIANGSU SHENGLIJIE SAFETY PRODUCTS CO.,LTD), it is highly probable that the testing was conducted in China. These types of performance studies are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The ground truth for these tests (e.g., irritation index, viability percentage, presence of holes, tensile strength) is established by standardized laboratory procedures and measurements, not by expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This information is not applicable. As stated above, the "ground truth" for these performance tests is determined by objective, standardized measurements rather than human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret and a comparative effectiveness with and without AI assistance is measured. This document is for disposable nitrile gloves, which do not involve such a scenario.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) study was not done. This concept applies to AI/ML software as a medical device. Disposable nitrile gloves are a physical medical device, and their performance is evaluated through physical and biological testing, not through algorithms.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, standardized measurements and laboratory observations according to established international and national standards (ISO 10993, ASTM D6124, ASTM D5151, ASTM D6319). This includes:

Quantitative measurements (e.g., primary irritation index, viability percentage, powder content, dimensions, tensile strength, elongation).
Qualitative observations based on standardized protocols (e.g., presence/absence of abnormal signs for sensitization, water leakage for holes).

8. The Sample Size for the Training Set

Not applicable. This device (disposable nitrile gloves) does not utilize a training set in the context of machine learning or AI models. The testing described is for physical and biological performance, not for developing an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary

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September 15, 2021

Jiangsu Shenglijie Safety Products Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K212009

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: June 21, 2021 Received: June 28, 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 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, 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212009

Device Name Disposable nitrile gloves

Indications for Use (Describe)

The Disposable nitrile 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 - K212009

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: JIANGSU SHENGLIJIE SAFETY PRODUCTS CO.,LTD Address: NO.88 SI ROAD RUDONGMAXI INDUSTRIAL ZONE MATANG TOWN, NANTONG JIANGSU, 226401, CHINA Phone Number: +86-13813628939 Contact: Andy Jiang Date of Preparation: 2021.06.21

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: 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 Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate device information

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

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

5.0 Indications for use

The Disposable nitrile 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	K212009	K171422
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Indications for use	The Disposable nitrilegloves 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, Disposablenitrile gloves, Non-Sterile	Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove,Non-Sterile	Same

Table1-General Comparison

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Single use	Yes	Yes	Same
Sterility or not	Non-Sterile	Non-Sterile	Same

Predicate	Designation	Measured Size				Tolerance
Device(K171422)		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
Proposed Device	Designation	Measured Size				Tolerance
		S		M	L	XL
	Length, mm	238		241	244	237	min
	Width, mm	82-86		97-99	108-111	115-118	±2
	Thickness, mm:
	Finger	0.13				min
	Palm			0.08			min

Table2 Device Dimensions Comparison

Analysis1 : The measured 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.

Table3 Performance Comparison

Item	Proposed device	Predicated device	Remark
Colorant	blue	White/ Blue/ Black/ Pink	Analysis 2
PhysicalProperties	Before Aging Tensile Strength	14MPa, min	14MPa, min	SAME
	Ultimate Elongation	500%min	500%min	SAME
	After Aging Tensile Strength	14MPa, min	14MPa, min	SAME
	Ultimate Elongation	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

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Powder Content	0.06 mg/glove	Meet the requirements of SIMILARASTM D6124
----------------	---------------	------------------------------------------------

Analysis 2: 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

Table4 Safety Comparison

Item	Proposed device	Predicated device	Remark
Material	Nitrile	Nitrile	SAME
Biocompatibility	IrritationUnder the conditions of the study, not an irritant	Comply with ISO10993-10	SAME
	SensitizationUnder conditions of the study, not a sensitizer.
	CytotoxicityUnder the conditions of the study, the device is potentially cytotoxic	Comply with ISO10993-5	SIMILAR
Label and Labeling	Meet FDA's Requirement	Meet FDA's Requirement	SAME

8.0 Summary of Non-Clinical Performance Testing

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

Table 5 Summary of Non-Clinical Performance Testing

No.	Name of the TestMethodology / Standard	Purpose	Acceptance Criteria	Results
1	ISO 10993-10:2010Biological Evaluation OfMedical Devices - Part10: Tests For IrritationAnd Skin Sensitization.	This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.	Skin Sensitization Test:provided grades less than 1, otherwise sensitization.	All grades are 0.All animals were survived and no abnormal signs were observed during the study.
2			Skin Irritation Test:If the primary irritation index is 0-0,4, the response category is Negligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe	The primary irritation index is 0.The response of the proposed device was categorized as negligible under the test condition

3	ISO 10993-5:2009	This part of ISO	The viab.% of the	Viab.% of 100% test article
	Biological Evaluation Of	10993 describes	100% extract of the	extract is 71.75%
	Medical Devices - Part	test methods to	test article is the final
	5: Tests For In Vitro	assess the in vitro	result, and if viability is	It means the proposed device
	Cytotoxicity	cytotoxicity of	reduced to <70% of	have no potential toxicity to
		medical devices.	the blank, it has	L-929 in the MTT method
			cytotoxic potential.

4	ASTM D6124-06	This standard is	powder residue limit of	0.06 mg /glove
	(Reapproved 2017),	designed to	2.0 mg
	Standard Test Method	determine the
	for Residual Powder on	amount ofresidual
	Medical Gloves	powder (or
		filter-retained
		mass) found
		on medical gloves
5	ASTM	This test method	Samples number: 125	no glove water leakage found
	D5151-06(Reapproved2	covers the	gloves
	015), Standard Test	detection of holes	AQL: 2.5 (ISO 2859)
	Method for Detection of	in	Criterion ≤7 gloves
	Holes in Medical Gloves.	medical gloves.	for water leakage


റ	ASTM	This specification	Sterility: no need	N.A.
	D6319-10(Reapproved	covers certain	Freedom from holes:	Please refer to No. 5 in table 5
	2015),Standard	requirements for	pl. Refer to No. 5 in	Dimensions:
	Specification For Nitrile	nitrile rubber	table 5	S: width: 82-86 mm
	Examination Gloves For	gloves used in	Dimensions:	Length 238-245 mm
	Medical Application.	conducting	S: width 80±10mm	M: width 97-99 mm
		medical	Length ≥220 mm	Length 243-249 mm
		examinations and	M: width 95±10mm	L: width 108-111 mm
		diagnostic and	Length ≥230 mm	Length 244-254 mm
		therapeutic	L: width 110±10mm	XL: width 115-118 mm
		procedures.	Length ≥230 mm	Length 237-246 mm
			XL: width 120±10mm	Thickness:
			Length ≥230 mm	Finger 0.13-0.15 mm
			Thickness:	Palm 0.08 mm
			Finger ≥0.05 mm
			Palm ≥0.05 mm
				Physical properties:
			Physical properties:	Before aging
			Before aging	Tensile strength 14.12-22.10MPa
			Tensile strength ≥	Ultimate Elongation 537.05% -

			14MPa	907.44%

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	Ultimate Elongation $\ge$ 500%After Accelerated AgingTensile strength $\ge$ 14MPaUltimate Elongation $\ge$ 400%Powder-free Residue:pl. Refer to No. 4 in table 5	After Accelerated AgingTensile strength 14.46-20.20MPaUltimate Elongation 542.91% - 856.03%Powder-free Residue:pl. Refer to No. 4 in table 5
--	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------

9. Summary of Clinical Performance Test

No clinical study is included in this submission.

10.0 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.