The Single-use medical latex examination gloves 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.

Device Description

The Single-use medical latex examination qloves 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. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a medical device: "Single-use medical latex examination gloves (LG100)". This document is not for an AI/ML-based medical device. Therefore, the questions related to AI/ML device testing (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (K214017) through non-clinical performance testing against established ASTM and ISO standards for examination gloves.

Here's the relevant information based on the provided text, primarily focusing on the acceptance criteria and performance of the glove:

Acceptance Criteria and Device Performance for Single-use Medical Latex Examination Gloves (LG100)

This device is not an AI/ML system, but rather a physical medical device (examination gloves). Therefore, the acceptance criteria and study data relate to physical, chemical, and biological properties of the gloves, not algorithmic performance.

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

Test Methodology	Purpose	Acceptance Criteria	Reported Performance
ASTM D3578-19	Physical Dimension	The actual measured dimension of the gloves shall meet the stated tolerance specified in Table 2 of the ASTM D3578-19: - Width ± 10mm - Length: XS-S 220 min, M-XL 230 min - Thickness (finger and Palm): 0.08 min	Meet the requirement
ASTM D3578-19	Determination of Physical Properties	Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM D3578-19. Before Aging: - Tensile Strength: 18 MPa min - Stress Elongation: 5.5 MPa max - Ultimate Elongation: 650% min After Accelerated Aging: - Tensile Strength: 14 MPa min - Ultimate Elongation: 500% min	Meet the requirement
ASTM D5151-19	Water Leak Test for Detection of Holes	The gloves shall be free from holes when tested in accordance with the method given in ASTM D5151. AQL=2.5	Meet the requirement
ASTM D6124-06 (Reapp. 2017)	Residual Powder Content Test	The powder residue content shall be not more than 2mg per glove.	Meet the requirement
ASTM D3578-19	Protein Content	≤ 200 ug/dm²	Meet the requirement
ISO 10993-5:2009	In vitro Cytotoxicity	Non-cytotoxicity	Failed (Potential toxicity Grade 3 or 4) Self-contradictory with the conclusion of "as safe"
ISO 10993-10:2010	Skin Sensitization	Non-sensitizing	Meet the requirement
ISO 10993-10:2010	Skin Irritation	Non-irritating	Meet the requirement
ISO 10993-11:2017	Systemic Toxicity	Non-systemic toxicity	Meet the requirement

Note: The results for "In vitro Cytotoxicity" indicate "Failed (Potential toxicity Grade 3 or 4)", which seems to contradict the overall conclusion of the device being "as safe, as effective, and performs as well as or better than the legally marketed predicate device". This would warrant further investigation if this were a complete regulatory review. However, the provided text is the basis for this answer.

The following questions are not applicable to this 510(k) submission as it pertains to a physical medical device (examination gloves) and not an AI/ML-based device:

Sample sizes used for the test set and the data provenance: Not applicable. Tests are conducted according to published standards (e.g., AQL for water leak tests), not on subjective data sets. The testing is non-clinical, done by the manufacturer (Fitone Latex Products Co., Ltd. Guangdong, China).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by objective physical and chemical testing standards, not expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on established international standards (ASTM, ISO) for physical, chemical, and biological properties of medical gloves (e.g., tensile strength, freedom from holes, protein content, cytotoxicity tests).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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September 24, 2022

Fitone Latex Products Co., Ltd. Guangdong % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room1308,Baohua International Plaza,West Guangzhong Road 555 Jingan District Shanghai. 200072 China

Re: K222693

Trade/Device Name: Single-use medical latex examination gloves (LG100) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 30, 2022 Received: September 6, 2022

Dear Stuart Situ:

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.

Bifeng Qian.M.D.,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

Submission Number (if known)

K222693

Device Name

Single-use medical latex examination gloves (LG100)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K222693

I. Submitter

Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China

Contact person: Christine Ou Position: Manager Tel.: 0759-7905808 E-mail: market-intl@fitonelatex.com Preparation

date: September 20, 2022

Submission Correspondent

Ms. Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: stuart.situ@landlink-healthcare.com

US Agent

Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476

II. Proposed Device

Device Trade Name:	Single-use medical latex examination gloves
Model:	LG100
Common name:	Latex Patient Examination Glove
Regulation Number:	21 CFR 880.6250
Regulatory Class:	Class I
Product code:	LYY
Review Panel:	General Hospital

III. Predicate Devices

510(k) Number:	K214017
Trade name:	Examination gloves-Type A (Latex gloves)
Common name:	Latex Patient Examination Glove

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Classification:	Class I
Product Code:	LYY
Manufacturer	Jiangxi Kemei Medical Apparatus & Instruments GroupCo., Ltd.

IV. Device description

The proposed device. The Single-use medical latex examination qloves 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.

The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.

V. Indication for use

Item	Proposed device(K222693)	Predicate device(K214017)	Discussion
Productname	Single-use medical latexexamination gloves	Examination gloves-TypeA(Latex gloves)	-
IndicationsFor Use	The Single-use medicallatex examination gloves is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner.	The Examination gloves-Type A (Latex gloves) isa disposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.	Same
ProductCode	LYY	LYY	Same

VI. Comparison of technological characteristics with the predicate devices Table 1 General Comparison of Single-use medical latex examination gloves

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Regulation No.	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
Powdered orPowdered free	Powdered free	Powdered free	Same
Material	Natural Rubber Latex	Natural Rubber Latex	Same
Color	No colour pigment added.Natural White	No colour pigment added.Natural White	Same
Dimensions	Length:6(XS): 238-241 mm61/2(S):240-245mm71/2(M): 240-245mm81/2(L):246-250mm9(XL): 246-252mm	Length:S: 240-244mmM: 241-245mmL: 242-245mm	SimilarMeetingrequirement ofASTM D3578
	Width:6(XS): 74-76 mm61/2 (S):80-84mm71/2 (M): 94-97mm81/2 (L): 105-108mm9(XL): 114-120mm	Width:S: 84-86mmM: 96-98mmL: 105-108mm	SimilarMeetingrequirement ofASTM D3578
	Palm Thickness: 0.11-0.13mmFinger Thickness: 0.13-0.16mm	Palm Thickness: 0.11-0.13mmFinger Thickness: 0.13-0.14mm	SimilarMeetingrequirement ofASTM D3578
Biocompatibility	Non-sensitizingNon-irritatingNon-systemic toxicity	Non-sensitizingNon-irritatingNon-systemic toxicity	Same
Tensilestrength	Before Aging $24.4$ MPa,minStress at500 %Elongation	BeforeAging $20.6$ MPa,minStress at500 %Elongation	SimilarMeetingrequirement ofASTM D
		$4.2$ Mpa,max	$5.1$ Mpa,max

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	After Aging	20.5 MPa, min	After Aging	18.9MPa, min	3578
Ultimate Elongation	Before Aging	650%, min	Before Aging	683%, min
	After Aging	524%, min	After Aging	623%, min
Freedom from Holes	Meets ASTM D5151-19 AQL=2.5		Meets ASTM D5151-19 AQL=2.5		Same
Protein Content	Meets ASTM D5712-2015		Meets ASTM D5712-2015		Same
Powdered residue	Meets ASTM D6124-06(Reapproved 2017)		Meets ASTM D6124-06(Reapproved 2017)		Same
Sterility	Non-sterile		Non-sterile		Same
Shelf life	3 Years		5 Years		Similar¹
Single Use	Yes		Yes		Same
Label and labeling	Meet FDA's Requirement		Meet FDA's Requirement		Same

1 The Shelf life of proposed device and predicate device is different; However, the product performance after 3 years has been determined based on accelerated aging study. The results can demonstrate that the performance of proposed device meets the ASTM D3578 requirements after 3 years accelerated aging.

VII. Non-Clinical Testing

Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.

. ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
. ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
. ASTM D3578-19 Standard Specification for Rubber Examination Gloves
. ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
. ASTM D7160-05 Standard Practice for Determination of Expiration Dating for medical Gloves
ISO 10993-1: 2009 Biological evaluation of medical devices Part1: Evaluation and .

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testing within a risk management process

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 5: Tests For systemic toxicity

Test Methodology	Purpose	Acceptance Criteria	Results
ASTM D3578-19	Physical Dimension	The actual measureddimension of thegloves shall be meetthe stated tolerancespecified in Table 2 ofthe ASTM D3578-19Width ± 10mmLength XS-S 220 minand M-XL 230 minThickness (finger andPalm): 0.08 min	Meet therequirement
ASTM D3578-19	Determination ofPhysical Properties	Before and afteraccelerated aging, thegloves shall conformto the physicalrequirements in theTable 3 of ASTMD3578-19Before Aging:Tensile Strength: 18MPa minStress Elongation: 5.5MPa maxUltimate Elongation:650% minAfter AcceleratedAging:Tensile Strength: 14MPa minUltimate Elongation:500% min	Meet therequirement
ASTM D5151-19	Water Leak Test forDetection of Holes	The gloves shall befree from hole whentested in accordancewith the method givenin ASTM D5151AQL=2.5	Meet therequirement
ASTM D6124-06(2017)	Residual PowderContent Test	The powder residuecontent shall be notmore than 2mg perglove.	Meet therequirement
ASTM D3578-19	Protein Content	$\leq$ 200 ug/dm²	Meet therequirement
ISO 10993-5:2009	In vitro Cytotoxicity	Non-cytotoxicity	FailedPotential toxicityGrade (3 or 4)
ISO 10993-10:2010	Skin Sensitization	Non-sensitizing	Meet therequirement
ISO 10993-10:2010	Skin irritation	Non-irritating	Meet therequirement
ISO 10993-11:2017	Systemic toxicity	Non-systemic toxicity	Meet therequirement

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VIII. Clinical Testing

No clinical study is included in this submission.

IX. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Single-use medical latex examination gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K214017.

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.