A 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.

Device Description

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).

AI/ML Overview

Acceptance Criteria and Device Performance Study for Non-Sterile, Powder-Free Latex Examination Gloves

This document outlines the acceptance criteria and the study conducted to demonstrate that the device, Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less), meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established industry standards and specific tests for biocompatibility. The table below summarizes these criteria and the reported performance.

CHARACTERISTICS	STANDARDS	ACCEPTANCE CRITERIA	DEVICE PERFORMANCE
Dimensions: overall length; width, palmand finger thickness	ASTM D 3578-05-e1	Adherence to ASTM D 3578-05-e1 standards	Meets
Tensile strength: before and after aging	ASTM D 3578-05-e1	Adherence to ASTM D 3578-05-e1 standards	Meets
Ultimate elongation: before and afteraging	ASTM D 3578-05-e1	Adherence to ASTM D 3578-05-e1 standards	Meets
Freedom from holes: pinholes AQL 2.5	ASTM D 3578-05-e1	AQL 2.5 (Acceptance Quality Limit) for pinholes	Meets
Powder Free Residue	ASTM D 3578-05-e1	Adherence to ASTM D 3578-05-e1 standards	Meets
Protein Level	ASTM D 3578-05-e1	50 micrograms or less protein	Meets
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation inRabbits	Passes irritation test	Passes
Biocompatibility: Sensitization	Guinea Pig Sensitization	Passes sensitization test	Passes

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

The provided document does not explicitly state the sample sizes used for each specific test within the ASTM D 3578-05-e1 standard or for the biocompatibility studies. However, the standard itself dictates sampling plans for various tests (e.g., AQL for pinholes).

Data Provenance: The studies were conducted by Siam Sempermed Corp., Ltd., an organization based in Thailand. The nature of the tests (physical properties, chemical analysis, and animal biocompatibility studies) indicates that the data is retrospective relative to the date of the 510(k) submission, meaning the tests were performed prior to the submission to demonstrate compliance. The country of origin for the data is Thailand, where the manufacturer is located.

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

For this type of device (medical gloves), the "ground truth" is not typically established by human experts in the same way as, for example, medical imaging diagnostics. Instead, the ground truth is defined by objective, measurable parameters outlined in the referenced standards (ASTM D 3578-05-e1) and established protocols for biocompatibility testing.

ASTM D 3578-05-e1: Compliance with this standard is determined through prescribed laboratory testing methods, not by expert consensus. Therefore, no number of human experts with specific qualifications like "radiologist with 10 years of experience" would be involved in establishing this ground truth. The "experts" would be qualified laboratory technicians performing the tests according to the standard.
Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These are standardized animal tests with defined pass/fail criteria. The interpretation of results would typically be done by qualified toxicologists or veterinarians specializing in animal studies, following established protocols. The number of such individual experts is not specified but is implicit in the execution of these regulatory-driven tests.

4. Adjudication Method (for the test set)

As described above, the "ground truth" for this device's performance is determined by adherence to established, quantitative standards and prescribed test protocols. Therefore, a human "adjudication method" like 2+1 or 3+1 (common in studies involving subjective interpretation, e.g., clinical diagnosis) is not applicable here. The results of the tests are objective and directly compared against the acceptance criteria outlined in the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study is not applicable and therefore was not done for this device. MRMC studies are used to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of AI in interpreting medical images or data. This device is a physical product (examination glove), not an AI diagnostic tool, so such a study would be irrelevant.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study is not applicable for this device. This device is a physical product, not an algorithm or AI model. Therefore, there is no "algorithm-only" performance to evaluate. The studies performed are to demonstrate the physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The type of ground truth used is predominantly objective, quantitative measurements against established industry standards and regulatory biological safety protocols.

ASTM D 3578-05-e1: Ground truth is defined by the specific values, ranges, and methodologies prescribed by this standard for dimensions, tensile strength, elongation, freedom from holes (AQL), and powder-free residue.
Protein Level: The ground truth is the quantitative measurement of protein, with an acceptance criterion of "50 micrograms or less."
Biocompatibility: Ground truth is established by the outcomes of validated animal tests (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization) against predefined "pass" criteria for these biological responses.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable for this device. Training sets are used in machine learning and AI development to teach an algorithm to recognize patterns. Since this device is a manufactured physical product, its characteristics are determined by the manufacturing process and material properties, not by an algorithm trained on data. There is no software or AI component that requires a training set.

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

As stated above, a "training set" is not applicable for this device. Therefore, the question of how its ground truth was established is moot.

Summary

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JUL·- 9 2010

510 (k) Summary As Required by 21 section 807.92 ( c)

1. Submitter Name: Siam Sempermed Corp., Ltd
1. Address: 352 Kanjanavanit Road. Pahtong Hatyai Songkhla. Thailand 90230
(+66) 74 291 471 3. Phone:
1. Fax: (+66) 74 471 111
1. Contract Person: Mrs. Parawan Paiyasan (Quality System manager)

Date summary prepared: 15 March , 2010

1. Official Correspondent: Sempermed USA Inc.
13900 49th Street North 8. Address: Clearwater, USA , FL 33762
727 787 7250 9. Phone:
1. Fax: 727 787 7558
Mr. William E. Harris 11. Contact person:
1. Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).
1. Device Common or usual name: Examination glove
1. Device Classification Name: Glove , Patient Examination , Latex
1. Description of the Device:

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less). 16. Intended use of the device:

This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.

17. Summary of The Technological Characteristics of The devices :(According Guidance for Industry and FDA Staff - Medical Glove Guidance Manual(January 22, 2008))

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less) are summarized with the following technological characteristics:

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimensions: overall length; width, palmand finger thickness	ASTM D 3578-05-e1	Meets
Tensile strength: before and after aging	ASTM D 3578-05-el	Meets
Ultimate elongation: before and afteraging	ASTM D 3578-05-e1	Meets
Freedom from holes: pinholes AQL 2.5	ASTM D 3578-05-e1	Meets
Powder Free Residue	ASTM D 3578-05-e1	Meets
Protein Level	ASTM D 3578-05-e1	Meets
Biocompatability	Primary Skin Irritation inRabbits	Passes
	Guinea Pig Sensitization	Passes

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18. Substantial Equivalents Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

19. Conclusion

It can be concluded that Non-Sterile, powder-frec latex examination gloves and protein claim (50 micrograms or less) will perform according to the glove performance standards referenced in section 17 above and meet ASTM standards, and FDA requirements. Consequently, this device is substantially equivalent to currently marketed devices. This device is safe and effective as the predicate device Siam Sempermed Latex Pattent Examination Glove , Powder free and protein claim (50 micrograms or less). Indeed , it is equivalent. This is better expressed in the tabulated comparison as below.

Technical comparison of specific elements is attached in the main submission.

FDA file reference number	510k number : K970794
Attachments inside notificationsubmission file	REFER TO APPENDIX I
TECHNOLOGICALCHARACTERISTICS	Comparison resultREFER TO ADDITIONAL TECHNICALCOMPARATIVE TABLE WITHIN 510KSUBMISSION
Indications for use	Identical
Target population	Identical
Design	Identical
Materials	Similar
Performance	Identical
Sterility	Not applicable
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Identical
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical (Not applicable)
Compatibility with environmentand other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical (Not applicable)
Thermal safety	Identical (Not applicable)
Radiation safety	Identical (Not applicable)

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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.

SEP 9 2010 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Siam Sempermed Corporation, Limited C/O Mr. William E. Harris President & Chief Executive Office Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762

Re: K100907

Trade/Device Name: Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 16, 2010 Received: June 22, 2010

Dear Mr. Harris:

This letter corrects our substantially equivalent letter of July 9, 2010.

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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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Page 2- Mr. Harris

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. wat
Anthony D. Watson, B.S., M.S., M.B.A.

Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K100907 510(k) Number (if known):

Device Name: Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less).

Indications For Use: A 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.

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

KIDO907 510(k) Number:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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でア

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.