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 betweeen patient and examiner.

Device Description

Non sterile, Powder free Nitrile Examination Glove, Blue ,Polymer coating with Chemotherapy claim .

AI/ML Overview

{
  "acceptance_criteria_and_performance_table": {
    "title": "Acceptance Criteria and Device Performance for Non-Sterile, Power-Free Nitrile Examination Glove",
    "headers": ["CHARACTERISTICS", "STANDARDS", "DEVICE PERFORMANCE"],
    "data": [
      ["Dimensions", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Physical Properties", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Freedom from pinholes", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Powder Free Residue", "ASTM D 6124-2006", "≤ 2 mg/glove"],
      ["Biocompatibility (Primary Skin Irritation in Rabbits)", null, "Passes"],
      ["Biocompatibility (Guinea Pig Sensitization)", null, "Passes"]
    ]
  },
  "sample_size_test_set": "Not specified; the document refers to performance data but does not detail the sample sizes for the specific tests.",
  "data_provenance": "Not specified explicitly in the provided text. The submitter is Siam Sempermed Corp., Ltd from Thailand, suggesting testing could have occurred there or in the US.",
  "number_of_experts_ground_truth_test_set": "Not applicable. The tests performed are objective, laboratory-based physical and chemical property assessments according to ASTM standards, and biocompatibility tests. Expert consensus is not required for establishing ground truth for these types of measurements.",
  "qualifications_of_experts": "Not applicable.",
  "adjudication_method": "Not applicable. The tests involve quantifiable measurements against established standards, not subjective assessments requiring adjudication.",
  "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data.",
  "effect_size_of_human_readers_with_ai_vs_without_ai_assistance": "Not applicable, as no MRMC study was performed and this device type does not involve AI assistance for human reader interpretation.",
  "standalone_performance_study": "Yes, a standalone (algorithm only without human-in-the-loop performance) was effectively done. The device's performance was evaluated against established ASTM and biocompatibility standards independently, without human interaction with an AI component.",
  "type_of_ground_truth_used": "Objective measurements from laboratory tests according to established international standards (ASTM) and biological response tests (biocompatibility).",
  "sample_size_training_set": "Not applicable. This device is a medical glove, not an AI/ML-based device that requires a training set.",
  "how_ground_truth_for_training_set_was_established": "Not applicable, as there is no training set for this device type."
}

Summary

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K080520

APR 3 0 2008

510 (k) Summary

As Required by 21 section 807.92 (c)

1. Submitter Name: Siam Sempermed Corp., Ltd
1. Address: 110 Kanjanavanit Road. Pathong Hatyai Songkhla.Thailand 90230
(+66) 74 291 648 3. Phone:
1. Fax: (+66) 74 291 650
Contract Person: Mrs. Sureerat Choosri (Product Manager) న్.
1. Date summary prepared: December 30, 2005

Official Correspondent: Sempermed USA Inc.

8. Address:	13900 49th Street NorthClearwater, USA, FL 33762
9. Phone:	727 787 7250
10. Fax:	727 787 7558

1. Contact person: Mr. William E. Harris

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

1. Description of the Device:
  Non sterile, Powder free Nitrile Examination Glove, Blue ,Polymer coating with Chemotherapy claim .

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:

Non sterile, Powder free Nitrile Examination Glove, Blue ,Polymer coating with Chemotherapy claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimensions	ASTM D 6319-00a (Re-approved2005)	Meets
Physical Properties	ASTM D 6319-00a (Re-approved2005)	Meets
Freedom from pinholes	ASTM D 6319-00a (Re-approved2005)	Meets
Powder Free Residue	ASTM D 6124-2006	$\u2264$ 2 mg/glove
Biocompatibility	Primary Skin Irritation in Rabbits	Passes
	Guinea Pig Sensitization	Passes

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

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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 , Polymer coating with chemotherapy claim 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 Non sterile Powder free Nitile Examination Glove Blue with Polymer coaling. Indeed, it is equivalent. 1This 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
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	Identical
Materials	Identical
Performance	Identical
Sterility	Identical (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 environment andother 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2008

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: K080520

Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: April 17, 2008 Received: April 23, 2008

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.

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 Eederal 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); 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sudite Y. Michaudmd.

Chiu Lin, Ph.D. 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): K0805 20

Non-sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Device Name: Coating, Tested for Use with Chemotherapy Drugs 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 betweeen 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)

Shila A. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K081520

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.