The nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

AI/ML Overview

The provided text describes the regulatory filing for Nitrile Examination Gloves and includes non-clinical testing results. It does not involve a medical device with an AI algorithm, a diagnostic purpose, or human-in-the-loop performance. Therefore, many of the requested fields are not applicable.

Here's the information based on the provided document:

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

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions	Length: S: ≥220mm; M/L/XL: ≥230mm	Length: >230mm / Pass
		Width: S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm	Width: S: 83-85mm / Pass; M: 94-96mm / Pass; L: 110-112mm / Pass; XL: 113-117mm / Pass
		Thickness: Finger: ≥0.05mm; Palm: ≥0.05mm	Thickness: Finger: 0.12-0.15mm / Pass; Palm: 0.08-0.10mm / Pass
ASTM D5151	Watertightness (Holes)	Meet the requirements of ASTM D5151 AQL 2.5	0/200 / Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0mg	0.1-0.3mg / Pass
ASTM D412	Physical Properties (Before Aging)	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500%	Tensile Strength: 17-38MPa / Pass; Ultimate Elongation: 501-565% / Pass
	Physical Properties (After Aging)	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400%	Tensile Strength: 18-43MPa / Pass; Ultimate Elongation: 500-564% / Pass
ISO 10993-5	Cytotoxicity	Under conditions of the study, device extract is cytotoxic (Note: The table entries are a bit confusing here, but the result suggests it was acceptable).	Reported result for ISO 10993-5 is "Under conditions of the study, device extract is cytotoxic" (This appears to be an acceptance criteria statement, not a 'Pass' for the device itself. A positive for cytotoxicity is usually undesirable, implying here it was within an acceptable range or a specific interpretation of the standard criteria. For similar devices, non-cytotoxicity is often the goal. However, without further context for their specific criteria, it's presented as stated in the table).
ISO 10993-11	Acute Systemic Toxicity	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10	Irritation	Under the conditions of the study, not an irritant	Under the conditions of the study, not an irritant / Pass
ISO 10993-10	Sensitization	Under conditions of the study, not a sensitizer	Under conditions of the study, not a sensitizer / Pass

2. Sample sized 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:
- For the Watertightness test (ASTM D5151), a sample size of 200 was used.
- Other tests (dimensions, powder content, physical properties, biocompatibility) do not explicitly state the sample size in the provided document, but typically these standards specify minimum sample numbers.
Data Provenance: The tests were conducted to verify that the proposed device met all design specifications. The document implies these were laboratory tests performed for the manufacturer, Shanxi Nacosa Medical Technology Co.,Ltd, which is located in China. The data would be prospective in nature, as it's generated specifically for the 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 device is a physical medical glove, not an AI or diagnostic device that requires expert ground truth for interpretation. The "ground truth" here is established by standardized testing methods and their inherent measurement criteria. Therefore, not applicable.

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

Not applicable, as this is laboratory testing against established standards, not interpretation by experts.

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 not an AI or diagnostic device.

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

Not applicable. This is not an AI or algorithm-based device.

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

The "ground truth" for this device's performance is defined by the acceptance criteria specified in recognized international and national standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993 series). The device's performance is measured against these numerical and qualitative benchmarks.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2021

Shanxi Nacosa Medical Technology Co.,Ltd % Boyle Wang Official Correspondent Shanghai Truthful information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K212924

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: September 7, 2021 Received: September 14, 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212924

Device Name Nitrile Examination Gloves

Indications for Use (Describe)

The nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

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 K212924

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

1.0 Submitter's Information

Name: Shanxi Nacosa Medical Technology Co.,Ltd Address: Chengxi Industrial Park, Wenxi Economic and Technological Development Zone, Yuncheng City, Shanxi Province, China. Phone Number: +86 15955123917 Contact: Lu Yingying Date of Preparation: Sept 7, 2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China 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): S, M, L, XL

3.0 Classification

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

4.0 Predicate Device Information

Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO.,LTD. Device: Nitrile examination gloves 510(k) number: K203593

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5.0 Indication for Use

The disposable medical nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

Table1-General Comparison
Item	Subject Device(K212924)	Predicated Device(K203593)	Comparison
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The nitrile examinationglove is intended to beworn on the hands ofexaminers toprevent contaminationbetween patient andexaminer. This is asingle-use, powder-free,non-sterile device.	The nitrile examinationglove is intended to beworn on the hands ofexaminers toprevent contaminationbetween patient andexaminer. This is asingle-use, powder-free,non-sterile device.	Same
Material	Nitrile	Nitrile	Same
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Colorant	Blue	Blue	Same
LabelingInformation	Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile	Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile	Same
Dimensions(mm)	Length(mm):>230;Width(mm):S: Average 84mmM: Average 95mm	Length:S (220mm min)M (230mm min)L (230mm min)XL (230mm min)	Similar

Table1-General Comparison

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		L: Average 111mmXL: Average 115mm	Width:Small (80 $\pm$ 10mm)Medium (95 $\pm$ 10mm)Large (110 $\pm$ 10mm)X large (120 $\pm$ 10mm)
		Meet the requirementsof ASTM D6319-19	meet the requirementsof ASTM D6319-19
Thickness(mm)		Finger: 0.12-0.15Palm: 0.08-0.10	Palm: 0.05mm minFinger: 0.05mm min	Similar
PhysicalProperties	BeforeAging	TensileStrength	17-38MPa	TensileStrength	14MPa, min	Similar
		UltimateElongation	501-565%	UltimateElongation	500% min	Similar
	AfterAging	TensileStrength	18-43MPa	TensileStrength	14MPa, min	Similar
		UltimateElongation	500-564%	UltimateElongation	400%min	Similar
Freedom fromHoles		Be free from holes whentested in accordancewith ASTMD5151AQL=2.5		Be free from holes whentested in accordancewith ASTMD5151AQL=2.5		Same
Powder Content		0.1-0.3mgMeet the requirements ofASTM D6124<2.0 mg/gloves		Meet the requirements ofASTM D6124<2.0 mg/gloves		Similar
Biocompatibility		ISO 10993-10;		ISO 10993-10;
		Under the conditions ofthe study, not an irritantor a sensitizer		Under the test conditionof study not a sensitizer.Under the test conditionof study not an irritant.		Same
		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.		Cytotoxicity is assessedvia rationale. Under thecondition of acutesystemic toxicity test, thetest article did not showacute systemic toxicity invivo.		Same
		ISO 10993-5Under conditions of thestudy, device extract iscytotoxic		N.A.		/

Analysis:

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The physical dimensions, physical properties and powder content are different with that of the predicate, but they all meet the requirements of ASTM D6319-19.

8.0 Summary of Non-clinical Testing

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 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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 toxicity.

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.

TestMethod	Purpose	Acceptance Criteria	Results
ASTMD6319	PhysicalDimensionsTest	Length(mm):S: ≥220;	Length(mm):> 230/Pass;
		M/L/XL: ≥230;	Width(mm):
		Width(mm):S: 80±10;	S: 83-85 /Pass
		M: 95±10;	M: 94-96/Pass
		L: 110±10;	L: 110-112/Pass
		XL: 120±10	XL:113-117/ Pass
		Thickness (mm):Finger: ≥0.05	Thickness (mm):Finger: 0.12-0.15/Pass
		Palm: ≥0.05	Palm: 0.08-0.10/Pass

ASTMD5151	WatertightnessTestfor	Meet the requirements of ASTM D5151AQL 2.5	0/200/Pass

Table 2 - Summary of non-clinical performance testing

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	Detection ofHoles
ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 < 2.0mg			0.1-0.3mg/Pass;
ASTMD412	Physicalproperties	BeforeAging	TensileStrength	≥14MPa	17-38MPa/Pass;
			UltimateElongation	≥500%	501-565%/Pass;
		AfterAging	TensileStrength	≥14MPa	18-43MPa/Pass;
			UltimateElongation	≥400%	500-564%/Pass;
ISO10993-5	Cytotoxicity	toxicity		Under conditions ofthe study, deviceextract is cytotoxic.
ISO10993-11	Acute SystemicToxicity	Non- acute systemictoxicity			Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass
ISO10993-10	Irritation	Non-irritating		Under the conditionsof the study, not anirritant/ Pass
ISO10993-10	Sensitization	Non-sensitizing		Under conditions ofthe study, not asensitizer./ Pass

9.0 Summarv of Clinical Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device K203593.

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.