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.

Device Description

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

AI/ML Overview

This is a 510(k) summary for Disposable Medical Nitrile Examination Gloves. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI-powered device, human readers, or a ground truth established by experts. Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of the information that can be extracted or noted as not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length: S: ≥220mm; M/L/XL: ≥230mm; Width: S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; Thickness: Finger: ≥0.05mm; Palm: ≥0.05mm	Length: > 240mm (Pass); Width: S: 84-88mm (Pass); M: 96-98mm (Pass); L: 106-108mm (Pass); XL: 110-113mm (Pass); Thickness: Finger: 0.11-0.13mm (Pass); Palm: 0.07-0.08mm (Pass)
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125/Pass (This implies 0 holes found in 125 samples, meeting AQL 2.5)
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0mg	0.20mg (Pass)
ASTM D412	Physical Properties (Before Aging)	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500%	Tensile Strength: 14.5-22 MPa (Pass); Ultimate Elongation: 590-890% (Pass)
ASTM D412	Physical Properties (After Aging)	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400%	Tensile Strength: 14.5-20 MPa (Pass); Ultimate Elongation: 535-690% (Pass)
ISO 10993-11	Systemic Toxicity	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo (Pass)
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study, not an irritant (Pass)
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer (Pass)

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

Sample Sizes:
- For the Watertightness Test (ASTM D5151): 125 samples are mentioned (0/125/Pass).
- For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), the document does not explicitly state the number of samples tested, but usually, these tests are performed on a representative sample set according to the respective standards.
Data Provenance: The tests were conducted internally or by accredited laboratories as part of the regulatory submission process for Lanhuo Medical Technology (Jiangsu) Co.,Ltd. The country of origin of the data is China, as the manufacturer and designated correspondent are based there. The data is prospective for this device, meaning the tests were performed on the actual device being submitted.

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

Not applicable. This document describes non-clinical performance testing of a medical device (nitrile gloves), not an AI algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., a hole is a hole, a measurement passes or fails a defined threshold).

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretations needing adjudication. The results are based on objective physical and chemical testing methods.

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 document does not describe a study involving human readers or AI assistance.

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

Not applicable. This document describes the performance testing of physical examination gloves, not an algorithm.

7. The Type of Ground Truth Used

Objective Test Standards and Specifications: The "ground truth" for the performance evaluation of the nitrile gloves is established by universally recognized and standardized test methods (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define objective criteria (e.g., specific dimensions, tensile strength, elongation percentages, maximum powder content, absence of holes, and specific biocompatibility responses) that the device must meet.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set."

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

Not applicable. As there is no training set, this question is not relevant.

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). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".

October 26, 2021

Lanhuo Medical Technology (Jiangsu) Co.,Ltd Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lu Jiazui Rd., Pudong Shanghai, Shanghai 200120 China

Re: K212363

Trade/Device Name: Disposable Medical 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: July 16, 2021 Received: July 30, 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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212363

Device Name

Disposable medical nitrile examination gloves

Indications for Use (Describe)

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

Production Use with CFR 211 Subpart D
Sample Use Consistent with CFR 211 Subpart I

__ 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 (K212363)

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

1.0 Submitter's Information

Name:	Lanhuo Medical Technology (Jiangsu) Co.,Ltd.
Address:	Industrial Park,Liuzhuang Town,Dafeng District,YanchengCity,Jiangsu Province,China
Tel:	+86-13917265389
Contact:	Liu Ying

Designated Submission Correspondent

Name:	Shanghai Truthful Information Technology Co., Ltd.
Address:	Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai200120 ,China
Tel:	+86-21-50313932
Contact:	Mr. Boyle Wang
Email:	Info@truthful.com.cn

Date of Preparation: Oct.20th,2021

2.0 Device Information

Trade name:	Disposable Medical Nitrile Examination Gloves
Common name:	Patient Examination Gloves
Classification name:	Non-powdered patient examination glove
Model(s):	S, M, L, XL
Production code:	LZA
Regulation number:	21CFR880.6250
Classification:	Class I
Panel:	General Hospital

3.0 Predicate Device Information

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

4.0 Indication for Use

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5.0 Device Description

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

6.0 Technological Characteristic Comparison Table

Item	Subject Device(K212363)	Predicate Device(K203593)
Product Code	LZA	LZA
Regulation No.	21CFR880.6250	21CFR880.6250
Class	I	I
Intended Use	The disposable medicalnitrile examination gloves areintended to be worn on thehands of examiners toprevent contaminationbetween patient andexaminer. This is a single-use, powder-free, non-steriledevice.	The nitrile examination gloveis intended to be worn on thehands of examiners toprevent contaminationbetween patient and examiner.This is a single-use,powder-free, non-steriledevice.
Material	Nitrile	Nitrile
Powdered orPowered free	Powdered free	Powdered free
Design Feature	Ambidextrous	Ambidextrous
Colorant	Blue	Blue
Labeling Information	Single-use indication,powder free, device color,device name, glove size andquantity,Non-Sterile	Single-use indication, powderfree, device color, devicename, glove size and quantity,Non-Sterile
Dimensions(mm)	Length:S:≥220;M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;	Length:S:≥220;M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;

Table1-General Comparison

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		XL: 120±10		XL: 120±10
Thickness(mm)		Finger: ≥0.05;		Finger: ≥0.05;
		Palm: ≥0.05		Palm: ≥0.05
PhysicalProperties	BeforeAging	TensileStrength	14MPa, min	TensileStrength	14MPa, min
		UltimateElongation	500% min	UltimateElongation	500% min
	AfterAging	TensileStrength	14MPa, min	TensileStrength	14MPa, min
		UltimateElongation	400%min	UltimateElongation	400%min
	Freedom fromHoles		Be free from holes when tested in accordance withASTMD5151 AQL=2.5		Be free from holes when tested in accordance withASTMD5151 AQL=2.5
	Powder Content		Meet the requirements ofASTM D6124		Meet the requirements ofASTM D6124
Biocompatibility		ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer		ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer
		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.		ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.
		ISO 10993-5Under conditions of thestudy, device extract iscytotoxic		ISO 10993-5Under conditions of the study,device extract is cytotoxic

7.0 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 10993-10:2010, 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.

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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;M/L/XL:≥230;Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10Thickness (mm):Finger: ≥0.05Palm: ≥0.05	Length:> 240/Pass;Width:S: 84-88 /PassM: 96-98/ PassL: 106-108/ PassXL:110-113/ PassFinger: 0.11-0.13/PassPalm: 0.07-0.08/Pass
		ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/125/Pass
		ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 <2.0mg	0.20mg/Pass;
		ASTMD412	Physicalproperties	Before AgingTensile Strength$≥14MPa$UltimateElongation$≥500%$	14.5-22/Pass;590-890/Pass;
				After AgingTensile Strength$≥14MPa$UltimateElongation$≥400%$	14.5-20/Pass;535-690/Pass;
				ISO10993-11	Systemic toxicity	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

Table 2 - Summary of non-clinical performance testing

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8.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

9.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Medical Nitrile Examination Gloves, 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.