(100 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 document describes the premarket notification (510(k)) for the "Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating" by Siam Sempermed Corp., Ltd. The study aims to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (Implied by "Meets" or direct value) | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 6319-00-ae³ | Meets ASTM D 6319-00-ae³ requirements | Meets |
| Physical Properties | ASTM D 6319-00-ae³ | Meets ASTM D 6319-00-ae³ requirements | Meets |
| Freedom from pinholes | ASTM D 6319-00-ae³ | Meets ASTM D 6319-00-ae³ requirements | Meets |
| Powder Free Residue | ASTM D 6124-2006 | ≤ 2 mg/glove | ≤ 2 mg/glove |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in Rabbits | Passed | Passed |
| Biocompatibility (Guinea Pig Sensitization) | Guinea Pig Sensitization | Passed | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specific tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, Biocompatibility). The tests reference ASTM standards (ASTM D 6319-00-ae³ and ASTM D 6124-2006), which would specify sampling methods and sizes.
The data provenance is from non-clinical performance testing conducted by Siam Sempermed Corp., Ltd., in Thailand (based on the submitter's address). The data is prospective in the sense that it was generated for the purpose of this 510(k) submission to demonstrate the device's adherence to standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device performance study, not a study involving human expert interpretation of data like imaging. The "ground truth" for the device's performance is established by standardized testing methods and their inherent pass/fail criteria or quantitative limits, as defined by ASTM standards and biological testing protocols.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret complex data and their interpretations need to be reconciled (e.g., in radiological studies). For material property testing and biocompatibility assessments, the results are derived directly from the test procedures, eliminating the need for adjudication of human interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for an examination glove, which does not involve human interpretation in the same way.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. This device is not an algorithm, but a physical product (a medical glove).
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Adherence to recognized industry standards: ASTM D 6319-00-ae³ for dimensions, physical properties, and freedom from pinholes.
- Quantitative measurement against a specified limit: ASTM D 6124-2006 for powder-free residue (≤ 2 mg/glove).
- Biological testing outcomes: "Passed" for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, indicating non-toxicity/non-sensitization according to established biological evaluation protocols.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI algorithm that requires a training set. The performance data is based on samples of the manufactured gloves being tested against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K07-0639
510 (k) Sumr
As Required by 21 section 807.92 (c)
-
- Submitter Name: Siam Sempermed Corp., Ltd
- 110 Kanjanavanit Road. Pathong Hatyai 2. Address: Songkhla.Thailand 90230
JUN 5 2007
- (+66) 74 291 648 3. Phone:
- (+66) 74 291 650 4. Fax:
-
- Contract Person: Mrs. Sureerat Choosri (Product Manager)
- Date summary prepared: February 15, 2007 6.
-
- Official Correspondent: Sempermed USA Inc.
- 13900 49th Street North Address: 8. Clearwater, USA , FL 33762
-
- Phone: 727 787 7250
- 727 787 7558 10. Fax:
-
- Contact person: Mr. William E. Harris
- Device Trade or Proprietary Name: Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating
-
- 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 with Polymer coating
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 6124-2006 | ≤2 mg/glove |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passed |
| Guinea Pig Sensitization | Passed |
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 if can of concluded that the Nortelen, rower standards referenced in section 17 above and meet ASTM coaliaged and FDA requirements. Consequently, this device is substantially equivalent to currently marketed Standados, and I 1971 roquention Concequents predicate device Siam Sempermed Nitrile, Examination Glove, devices. This donee is sale as s 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: K060753 |
|---|---|
| Attachments inside notificationsubmission file | REFER TO APPENDIX 1 |
| Comparison result | |
| TECHNOLOGICALCHARACTERISTICS | REFER TO ADDITIONAL TECHNICALCOMPARATIVE TABLE WITHIN 510KSUBMISSION |
| 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 environment andother devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Not applicable |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
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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
JUN 1 5 2007
Re: K070639
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: May 30, 2007 Received: May 31, 2007
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.
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
长070639 510(k) Number (if known):
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)
Gesika Taylor - for Sheila Murphy
ision Sign-Off) Livision of Anesthesiology, General Ho Imaction Control, Dental
Page 1 of
510(k) Number: K070639
C2
§ 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.