Disposable device intended for medical purposes that is worn on the examiner's hand(s) or finger(s) to prevent contamination between patient and examiner.

Device Description

Product is a light and flexible glove, in standard sizes, for use in examination procedures, sold non-sterile and intended to be disposed of after use with each patient.

AI/ML Overview

Acceptance Criteria and Device Performance Study for CLK International Powder-Free Latex Examination Glove

This document outlines the acceptance criteria and the study performed to demonstrate that the CLK International Powder-Free Latex Examination Glove meets these criteria, based on the provided 510(k) summary (K974371).

1. Table of Acceptance Criteria and Reported Device Performance

The CLK International Powder-Free Latex Examination Glove is assessed against the requirements of ASTM D3578 voluntary standards for latex examination gloves, as well as biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1.

Acceptance Criteria Standard	Specific Test/Characteristic	Acceptance Criteria (from ASTM D3578 and ISO-10993)	Reported Device Performance	Comments
ASTM D3578	Physical Characteristics (before aging)	Meets ASTM D3578 requirements	Meets ASTM D3578 requirements	(Details not explicitly provided in the summary but implied)
ASTM D3578	Physical Characteristics (after aging)	Meets ASTM D3578 requirements	Meets ASTM D3578 requirements	(Details not explicitly provided in the summary but implied)
ASTM D3578	Evaluation of Leakage	Meets ASTM D3578 requirements	Meets ASTM D3578 requirements	(Details not explicitly provided in the summary but implied)
ISO-10993 (modified by FDA G95-1)	Primary Dermal Irritation	Meets ISO-10993 requirements	Meets ISO-10993 requirements	(Details not explicitly provided in the summary but implied)
ISO-10993 (modified by FDA G95-1)	Maximization Sensitization	Meets ISO-10993 requirements	Meets ISO-10993 requirements	(Details not explicitly provided in the summary but implied)

Note: The 510(k) summary states that "Characteristics of the CLK Int'l latex powder-free examination gloves are compared with ASTM D3578 in Attachment I, Table I" and "Tests show they meet the requirements of ASTM D3578 for latex examination gloves." However, the actual Attachment I, Table I, and detailed numerical results are not provided in the excerpt. Similarly, for biocompatibility, it states "biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1," again without specific data points in the provided text.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., physical characteristics, leakage, biocompatibility). It only generally refers to "Tests" and "Test Data."

Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It implies the data was collected specifically for the purpose of demonstrating equivalence, suggesting it was prospectively generated to meet the defined standards.

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

This information is not applicable in the context of this device. The ground truth for this device (a Class I medical device, examination glove) is established by adherence to recognized voluntary consensus standards (ASTM D3578) and international biocompatibility standards (ISO-10993 modified by FDA guidance), rather than expert consensus on medical images or clinical outcomes. The "experts" in this context would be the testing laboratories and their qualified personnel who perform the standardized tests according to the specified methodologies.

4. Adjudication Method for the Test Set

This information is not applicable. As the ground truth is based on objective, standardized test methods defined by ASTM and ISO, there is no need for expert adjudication methods (like 2+1 or 3+1 consensus) that are typically used for subjective assessments (e.g., medical image interpretation). The tests produce quantifiable results that either meet or do not meet the predefined criteria.

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 devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is being evaluated. For a medical glove, performance is measured against physical and biological standards, not through human reader interpretation.

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

This concept is not applicable to this device. A medical glove does not involve an algorithm or AI. Its performance is intrinsic to its physical and material properties.

7. The Type of Ground Truth Used

The ground truth used for this device is based on two main types:

Standardized Performance Metrics: Defined by ASTM D3578 for physical characteristics (e.g., tensile strength, elongation, freedom from holes).
Biocompatibility Standard Metrics: Defined by ISO-10993 (modified by FDA G95-1) for biological safety (e.g., dermal irritation, sensitization).

These are objective, quantifiable measures established by industry and regulatory bodies to ensure the safety and efficacy of medical gloves.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for AI/ML algorithms where a model learns from data. A medical glove is a physical product, not an algorithm. Its properties are inherent to its manufacturing process and materials.

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

This information is not applicable for the reasons stated above.

Summary

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APR 21 1998

K974371

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter: George Q. Kuo, M.D., CLK International, Inc., 28 East Broadway, 1. 2nd Floor, New York, NY, 10002. Ph: (212) 334-3953
Classification Names and Numbers: Latex "Powder-Free" Examination Glove, 11. 80LYY, Class I
Common/Usual Name: Latex "Powder-Free" Examination Glove (11.
Proprietary Names: CLK Int'l. Powder Free Latex Examination Glove IV.
Establishment Registration Number: In Progress V.
VI. Classification: Class I

VII. Performance Standard:

None established under section 514. Meets ASTM D3578 voluntary standards.

VIII. Description of the Device:

Product is a light and flexible glove, in standard sizes, for use in examination procedures, sold non-sterile and intended to be disposed of after use with each patient.

IX. Substantial Equivalent:

The CLK International glove is substantially equivalent to latex powder-free examination gloves cleared under the premarket-510(k)process since about 1990. It complies with the required standard (see above) as do equivalent gloves. Characteristics of the CLK Int'l latex powder-free examination gloves are compared with ASTM D3578 in Attachment I, Table I.

The "510(k) Substantial Evidence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended use, a disposable device intended for medical purposes that is worn on the examiner's hand(s) or finger(s) to prevent contamination between the patient and the examiner. These are the same as those of the predicate devices. These products also have the same intended uses as similar products cleared for marketing by the 510(k) process.
1. The technical characteristics for this product are the same as those for the predicate devices and those currently on the market that are prepared from rubber materials.

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The technical characteristics for this product are the same as those for the 2. predicate devices and those currently on the market that are prepared from rubber materials.
Descriptive information provided shows that the materials from which the CLK 3. latex powder-free examination gloves made are substantially equivalent to (nearly identical with) those of similar products and are to be used for identical purposes, currently on the market. Tests show they meet the requirements of ASTM D3578 for latex examination gloves.
The FDA "Decision-Making Process" chart was used and appears in 4. Attachment V.

Data used in determining substantial equivalence include those required by ASTM D3578 and biocompatability test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1.

Summary of Test Data Used in Determining Equivalence: Physical Characteristics, before and after aging. Evaluation of Leakage. Primal Dermal Irritation. Maximization Sensitization (ISO)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1998

George Q. Kuo, M.D. President CLK International, Incorporated 28 East Broadway, 2nd Floor New York, New York 10002

K974371 Re : CLK International Powder-Free Latex Trade Name: Examination Glove Requlatory Class: I Product Code: LYY March 30, 1998 Dated: Received: March 31, 1998

Dear Dr. Kuo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Dr. Kuo

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA asboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance. at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Applicant:	CLK International, Inc.
510(k) Number:	Not Applicable K974371
	POWDER FREE
Device Name:	CLK Intl. Latex Patient Examination Glove
Indications for use:

Disposable device intended for medical purposes that is worn on the examiner's hand(s)

or finger(s) to prevent contamination between patient and examiner.

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Concurrence of CDRH Office of Device Evaluation (ODE)

14 1 17 (Division Sign-Off) Division of Dental, Infection Control, and General Huapital Devices 510(k) Nymbar OR

Prescription Use Per 21 CFR 801.109

3.0

Over-The-Counter (Optional Format 1-2-96)

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.