A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).

AI/ML Overview

The provided 510(k) summary for the "Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E and protein claim (50 micrograms or less)" does not contain a study to prove the device meets specific acceptance criteria in the manner of a typical clinical performance study for an AI/ML device or diagnostic tool. Instead, this submission is an Abbreviated 510(k) based on substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794).

The acceptance criteria here are primarily regulatory and performance characteristics being compared to the predicate device, demonstrating that the new device is as safe and effective as the previously cleared one.

However, I can extract the information requested based on the context of a 510(k) submission for a medical glove.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating "substantial equivalence" to a predicate device. This involves comparing technological characteristics and showing that the new device is as safe and effective. The reported device performance is implicitly that it meets or is comparable to the predicate device across various parameters.

Acceptance Criteria Category	Specific Criteria/Comparison to Predicate	Reported Device Performance
General Characteristics	Substantially Equivalent to predicate device (K970794)	Device is substantially equivalent to K970794
Indications for Use	Identical to predicate device	Identical
Target Population	Identical to predicate device	Identical
Design	Similar to predicate device	Similar
Materials	Similar to predicate device (Latex, polymer coating, aloe, vitamin E)	Similar
Performance	Identical to predicate device (e.g., barrier integrity, physical properties)	Identical (Specific performance data would be in the "additional technical comparative table" mentioned as "attached in the main submission" but not provided here.)
Sterility	Identical to predicate device (Non-sterile)	Identical
Biocompatibility	Identical to predicate device	Identical
Mechanical Safety	Identical to predicate device	Identical
Chemical Safety	Identical to predicate device	Identical
Anatomical Sites	Identical to predicate device (Worn on examiner's hand)	Identical
Human Factors	Identical to predicate device	Identical
Protein Claim	Protein content ≤ 50 micrograms (as implied by device name)	Implied to meet this claim (specific measurement data not in summary)
Standards Met	Identical to predicate device (e.g., ASTM standards for medical gloves)	Identical (Specific standards not listed in the summary, but presumed to be met as part of "Performance" and "Mechanical/Chemical Safety".)

Study Details (as applicable for a 510(k) of a medical glove)

Given that this is a 510(k) for a medical glove based on substantial equivalence, the "study" referred to generally involves a comparison of technical characteristics and performance testing rather than a clinical trial with experts establishing ground truth in the way of an AI/ML diagnostic.

Sample size used for the test set and the data provenance:
- The provided summary does not detail specific sample sizes for performance tests (e.g., tensile strength, puncture resistance, protein content). Such data would typically be found in the "additional technical comparative table" mentioned but not included in this extract.
- Provenance: Not explicitly stated, but typically these tests are conducted internally by the manufacturer (Siam Sempermed Corp., Ltd.) during product development and quality control.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the sense of clinical ground truth. For a medical glove, "ground truth" relates to objective physical, chemical, and biological properties (e.g., dimensions, barrier integrity, protein content, biocompatibility). These are established through standardized testing procedures, not by human expert interpretation.
- The experts involved would be quality engineers, chemists, and microbiologists conducting the tests, often overseen by qualified staff (e.g., Dr. Poonsuk Cherdkiatgumchai, Chief Quality Officer).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in interpreting complex clinical data (e.g., radiology reads). For a physical device like a glove, test results are typically objective measurements against engineering specifications or established standards (e.g., ASTM).
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 device is a medical glove, not an AI/ML diagnostic tool. There are no "human readers" to assist in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical glove, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for a medical glove refers to its objective, measurable physical, chemical, and biological properties as defined by relevant standards (e.g., ASTM D3577 for examination gloves, ISO 10993 for biocompatibility) and regulatory requirements (e.g., protein content limits).
The sample size for the training set:
- Not applicable. This device is a physical product, not an AI/ML model that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. No training set is used for this type of device.

Summary

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K024121

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

Submitter Name: Siam Sempermed Corp., Ltd
Address: 110 Moo 8 Kanjanavanit Road. Pathong Hatyai

Songkhia. Thailand 90230 3. Phone: (++66) 074 291 648
1. Fax: (++66) 074 291 650
1. Contract Person: Dr. Poonsuk Cherdkiatgumchai (Chief Quality Officer)
1. Date summary prepared: October 29, 2002
1. Official Correspondent: Sempermed USA Inc.
30798 US Hwy. 19N 8. Address: .

Palm Harbor, USA , FL 34684

1. Phone: 727 787 7250
727 787 7558 10. Fax:
1. Contact person: Mr. William E Harris
1. Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E and protein claim (50 micrograms or less).

Device Common or usual name: Examination glove

1. Device Classification Name: Glove , Patient Examination , Latex
1. Substantial Equivalency is claimed against the following device :

Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794 (refer to Appendix 1 for FDA website printout.

This notification for the non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less) is of the ABBREVIATED type as per the declaration of conformity on page 4 of this summary.

1. Description of the Device:
  Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).
1. 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
1. Safety and effectiveness of the device:
  This device is safe and effective as the predicate device Siam Sempermed Latex Examination Glove , Powder free. Indeed , it is equivalent

This is better expressed in the tabulated comparison (Paragraph 19 below)

1. Summary comparing technological characteristics with other predicate device:
  General comparison result between non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less) and predicate device (Siam Sempermed Latex Examination Glove, Powder Free) is tabulated below.

3.1

This document and its contents are confidential. Do not discuss with or give access to people not designated.

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KC2 4/21

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 1
TECHNOLOGICALCHARACTERISTICS	Comparison resultREFER TO ADDITIONAL TECHNICALCOMPARATIVE TABLE WITHIN 510KSUBMISSION
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Identical
Sterility	Identical
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)

This document and its contents are confidential. Do not discuss with or give access to people not designated.

· · · ·

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a flowing, abstract manner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

·Siam Sempermed Corporation Limited C/O Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K024121

Trade/Device Name: Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, Vitamin E and Protein Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 29, 2002 Received: December 16, 2002

Dear Mr. Devine

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. 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 such 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. Devine

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulstowski

Timothy A. Ulatowski 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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DICATIONS FOR USE

Siam Sempermed Corp., Ltd. Applicant: _

Ko24121 510(k) Number: __

Device Name: Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and 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 to prevent contamination between patient and examiner.

AB. Jay. Clin

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

510(k) Number: K024121

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.