A powder-free 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 Nitrile Examination Glove, Blue.

AI/ML Overview

The provided text describes a 510(k) summary for a Non-sterile, Powder-free Nitrile Examination Glove, Blue. This is a medical device, and the information presented is for its regulatory clearance, not a study evaluating an AI device or a diagnostic tool. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device and its regulatory submission.

The document focuses on demonstrating that the new glove is "substantially equivalent" to an already legally marketed predicate device by meeting established performance standards.

Here's an analysis of the provided information, addressing the applicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

CHARACTERISTICS	STANDARDS (Acceptance Criteria)	DEVICE PERFORMANCE
Dimensions: overall length; width, palm and finger thickness	ASTM D 6319-10	Meets
Tensile strength: before and after aging	ASTM D 6319-10	Meets
Ultimate elongation: before and after aging	ASTM D 6319-10	Meets
Freedom from holes: pinholes AQL 2.5	ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6319-10	Meets
Biocompatability (Primary Skin Irritation in Rabbits)	ASTM D 6319-10 (Implicit, as it's a standard for examination gloves)	Passes
Biocompatability (Guinea Pig Sensitization)	ASTM D 6319-10 (Implicit, as it's a standard for examination gloves)	Passes
Dimensions: overall length; width, palm and finger thickness	ASTM D 6319-10	Meets

Note: "ASTM D 6319-10" refers to "Standard Specification for Nitrile Examination Gloves for Medical Application," which outlines the specific acceptance criteria (e.g., minimum tensile strength, maximum pinhole AQL, etc.) for each characteristic. The document states the device "Meets" or "Passes" these standards.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The testing for glove performance standards like ASTM D 6319-10 typically involves taking samples from production lots. The specific number of gloves tested for each characteristic (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM standard itself and quality control procedures, but this detail is not present in the 510(k) summary.
Data Provenance: The manufacturer is Siam Sempermed Corp., Ltd, located in Songkhla, Thailand. Therefore, the data would have originated from their testing facilities in Thailand. The data is based on non-clinical performance testing of the device's physical and biocompatibility characteristics, conducted to demonstrate compliance with the ASTM standard. This is prospective data generated for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For this type of device (medical glove), "ground truth" is established by adherence to established, objective, and quantitative physical and chemical standards (e.g., ASTM D 6319-10, biocompatibility testing protocols). There are no human "experts" interpreting results like in an image analysis or diagnostic study to establish a ground truth in the typical sense. Laboratory technicians and quality control personnel perform the tests according to standardized protocols.

4. Adjudication method for the test set

Not Applicable. Adjudication is typically used in studies where there is subjective interpretation or disagreement among observers (e.g., radiologists). For objective glove performance testing, the results are quantitative measurements compared directly against a standard. If a test fails, it fails; there is no 'adjudication' process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not Applicable. MRMC studies are used to evaluate diagnostic performance with human readers. This document describes a physical medical device (a glove), not a diagnostic or AI-driven system.

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

Not Applicable. This device is a physical product and does not involve algorithms or AI.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective physical and chemical measurements compared against the acceptance criteria defined by recognized consensus standards, specifically ASTM D 6319-10 for physical properties, and standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These are quantitative, laboratory-based measurements.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device; therefore, there is no "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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K122 363

SEP 1 0 2012

510 (k) Summary

As Required by 21 section 807.92 (c)

1. Submitter Name: Siam Sempermed Corp., Ltd
10 Soi 10 Phetkasem Rd. Hatvai 2. Address: Songkhla. Thailand 90110
(+66) 74 344 663 3. Phone:
(+66) 74 344 677 4. Fax:

Mr. Anan Pruksanusak (Chief Operations Officer) Contract Person: 5.

Date summary prepared: April 07, 2012 6.

Official Correspondent: Sempermed USA Inc.

13900 49th Street North Address: 8. Clearwater, USA , FL 33762
1. Phone: 727 787 7250
1. Fax: 727 787 7558
1. Contact person: Mr. William E. Harris

Device Trade or Proprietary Name: Non sterile, Powder free Nitrile Examination Glove, Blue.
Device Common or usual name: Examination glove
Device Classification Name: Nitrile Patient Examination Glove (Powder free, Blue color)

15. Description of the Device:

Non sterile, Powder free Nitrile Examination Glove, Blue.

1. Intended use of the device:
  A powder-free 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.

17. Summary of The Technological Characteristics of The devices:

Non-sterile, Powder free Nitrile Examination Glove, Blue is summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions: overall length; width,palm and finger thickness	ASTM D 6319-10	Meets
Tensile strength: before and after aging	ASTM D 6319-10	Meets
Ultimate elongation: before and afteraging	ASTM D 6319-10	Meets
Freedom from holes: pinholes AQL 2.5	ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6319-10	Meets
Biocompatability	Primary Skin Irritation in RabbitsGuinea Pig Sensitization	PassesPasses
Dimensions: overall length; width,palm and finger thickness	ASTM D 6319-10	Meets

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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 the Non sterile, Powder free Nitrile Examination Glove, Blue 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 Corp., Ltd Nitrile, Examination Glove, Blue, Powder free. Indeed, it is equivalent. This is better expressed in the tabulated comparison as below.

A technical comparison process flow chart is offered on the following page.

FDA file reference number ofpredicate device	510k number : K083755 (Non-Strile, Powder FreeNitrile Examination Glove, with Polymer Coating.Tested for use with Chemotherapy Drugs
TECHNOLOGICALCHARACTERISTICS	See additional details in main submission, Section4, Subpart H
Indications for use	Identical
Target population	Identical
Design	Similar
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	Not applicable
Compatibility with environmentand other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Not applicable
Dimensional standards	Identical
Physical properties	Identical
Thermal safety	Not applicable
Radiation safety	Not applicable
Production process	Similar, new device is online chlorinated. Seefollowing page for more information
Labeling	Similar: new device lacks a chemotherapy labelingclaim and associated statements

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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 a stylized caduceus symbol, which is a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

SEP 10 2012

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

Re: K122363
Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 6. 2012 Received: August 6, 2012

Dear Mr. Harris:

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. 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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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

O'Shaughnessy

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

510(k) Number (if known): ¡¡ / 22 363

Device Name: Non-sterile, Powder-free Nitrile Examination Glove, Blue

Indications For Use: A powder-free 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.

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)

Amani Abdulla Al-Kathiri

of Anestheslology, General Hospital n Control, Dental Devices

510(k) Number, K122363

Page 1 of __

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.