(37 days)
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.
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating
This is a 510(k) summary for a non-sterile, powder-free nitrile examination glove. It outlines the device's characteristics, intended use, and a comparison to established standards and a predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 6319-00-ae3 | Meets ASTM D 6319-00-ae3 | Meets |
| Physical Properties | ASTM D 6319-00-ae3 | Meets ASTM D 6319-00-ae3 | Meets |
| Freedom from pinholes | ASTM D 6319-00-ae3 | Meets ASTM D 6319-00-ae3 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | ≤2 mg/glove (as per standard) | ≤2 mg/glove |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for testing each characteristic. It only states that the performance tests were conducted. The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. The country of origin of the data is not explicitly stated for the testing itself, but the manufacturer is based in Thailand. The study is retrospective in the sense that the testing was conducted prior to the submission for regulatory approval.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable to this type of device. The "ground truth" for the performance characteristics of an examination glove is defined by the technical specifications and testing methods described in the referenced ASTM standards (e.g., ASTM D 6319-00-ae3, ASTM D 6124-2001) and biocompatibility test protocols. These standards dictate objective measurements rather than subjective expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. The performance testing of examination gloves involves laboratory measurements against established standards, not a process requiring adjudication among human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tools where human interpretation plays a significant role and can be enhanced by AI assistance. This device is a disposable medical glove, and its performance is assessed through physical and chemical testing, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not a function of an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on established industry standards and scientifically recognized test methods. Specifically:
- ASTM D 6319-00-ae3: Specifies ground truth for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from pinholes for nitrile examination gloves. These are objective, measurable criteria.
- ASTM D 6124-2001: Specifies the ground truth for powder-free residue, which is a quantitative measurement.
- Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These involve standardized animal testing protocols where "passes" indicates the absence of a defined level of adverse reaction, serving as the ground truth for biological safety.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for manufacturing such a device would involve process control and quality assurance, not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of this 510(k) submission for a physical medical device like an examination glove.
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α0753
510 (k) Summary
As Required by 21 section 807.92 (c)
APR 2 7 2006
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- Submitter Name: Siam Sempermed Corp., Ltd
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- Address: 110 Kanjanavanit Road. Pathong Hatyai Songkhla. Thailand 90230
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- Phone: (+66) 74 291 648
- বে Fax: (+66) 74 291 650
ર્જ Contract Person: Mrs. Sureerat Choosri (Product Manager)
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- Date summary prepared: December 30, 2005
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- Official Correspondent: Sempermed USA Inc.
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- 13900 49th Street North Address: Clearwater, USA , FL 33762
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- Phone: 727 787 7250
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- Fax: 727 787 7558
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- Contact person: Mr. William E. Harris
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Device Trade or Proprietary Name: Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating
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Device Common or usual name: Examination glove
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Device Classification Name: Nitrile Patient Examination Glove (Powder free, Blue color)
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- Description of the Device:
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer toating
- Description of the Device:
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 with Polymer coated are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 6319-00-ae3 | Meets |
| Physical Properties | ASTM D 6319-00-ae3 | Meets |
| Freedom from pinholes | ASTM D 6319-00-ae3 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | ≤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
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
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19. Conclusion
It can be concluded that the Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating will perform according to the glove performance standards referenced in section 17 above and many 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 Nitrile, Evany intion Glove, Blue, Powder free. 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: K000323 |
|---|---|
| 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 (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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head, resembling feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SIAM Sempermed Corporation. Limited C/O Mr. William E. Harris President & CEO Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762
APR 2 7 2006
Re: K060753
Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 21, 2006 Received: March 21, 2006
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 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); 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.
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): K 0607 53
Non-sterile, Powder-Free Nitrile Examination Glove, Blue with Device Name: Polymer Coating 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
X 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)
Siale M. Luysey 4/24/64
logy, General Hospit
Medical Devices
K400753
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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§ 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.