(76 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 between patient and examiner.
Non-Sterile, powdered latex examination gloves.
The acceptance criteria for the "Non-sterile, powdered latex examination gloves" and the study proving adherence to these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from pinholes | ASTM D 3578-05 | Meets |
| Powdered Residue | ASTM D 3578-05 | Meets |
| Protein Level | ASTM D 3578-05 | Meets |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in Rabbits | Passes |
| Biocompatibility (Guinea Pig Sensitization) | Guinea Pig Sensitization | Passes |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., freedom from pinholes, physical properties, etc.). It refers to "The performance test data of the non-clinical tests that support a determination of substantial equivalence" suggesting that tests were conducted.
The data provenance is not explicitly mentioned as country of origin but implies the tests were conducted by the manufacturer, Siam Sempermed Corp., Ltd, based in Thailand. The nature of the tests (e.g., ASTM standards for physical properties, animal studies for biocompatibility) indicates that these were likely prospective laboratory tests conducted to meet established standards for medical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for these tests is implicitly defined by the ASTM standards and the biological test methodologies. For example, "Passes" for Biocompatibility (Primary Skin Irritation in Rabbits) signifies that the results fell within the acceptable parameters defined by the test method, rather than being determined by expert consensus on specific device defects.
4. Adjudication method for the test set
Not applicable. The tests mentioned (e.g., ASTM D 3578-05, Primary Skin Irritation in Rabbits) are objective laboratory or animal studies with clear pass/fail criteria based on predefined specifications or biological responses. They do not involve human interpretation or adjudication in the sense of consensus building among experts.
5. 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 physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As this is a physical medical device, there is no algorithm or AI component to evaluate in a standalone capacity.
7. The type of ground truth used
The ground truth used for evaluating the device's performance is based on:
- Established Industry Standards: ASTM D 3578-05 for various physical characteristics (dimensions, physical properties, freedom from pinholes, powdered residue, protein level).
- Standardized Biological Test Methods: "Primary Skin Irritation in Rabbits" and "Guinea Pig Sensitization" for biocompatibility.
These methods define the objective criteria that the device must meet to be considered acceptable.
8. The sample size for the training set
Not applicable. This device is a physical medical product, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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SEP 1 7 2008
510 (k) Summary
As Required by 21 section 807.92 (c)
-
- Submitter Name: Siam Sempermed Corp., Ltd
- 352 Kanjanavanit Road. Pahtong Hatyai Songkhla. Thailand 90230 2. Address:
- (+66) 74 291 471 3. Phone:
- (+66) 74 471 337 4. Fax:
-
- Contract Person: Mrs. Parawan Paiyasan (Quality System Manager)
-
- Date summary prepared: June 20, 2008
-
- Official Correspondent: Sempermed USA Inc.
- 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
- 727 787 7250 9. Phone:
- 727 787 7558 10. Fax:
- Mr. William E. Harris 11. Contact person:
-
- Device Trade or Proprietary Name: Non-sterile, powdered latex examination gloves.
-
- Device Common or usual name: Examination glove
-
- Device Classification Name: Glove , Patient Examination , Latex
-
- Description of the Device:
Non-Sterile, powdered latex examination gloves.
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, powdered latex examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from pinholes | ASTM D 3578-05 | Meets |
| Powdered Residue | ASTM D 3578-05 | Meets |
| Protein Level | ASTM D 3578-05 | Meets |
| Biocompatability | Primary Skin Irritation in RabbitsGuinea Pig Sensitization | PassesPasses |
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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 Non-Sterile, powdered latex examination gloves 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 Latex Examination Glove , Powdered. 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: K895642 |
|---|---|
| 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 | 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 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) |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2008
Siam Sempermed Corporation, Limited C/O Mr. John Calhoun Manager of Regulatory Affairs Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762
Re: K081910
Trade/Device Name: Non-Sterile, Powdered Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 26, 2008 Received: August 29, 2008
Dear Mr. Calhoun:
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 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
510(k) Number (if known):
Device Name: Non-Sterile, Powdered Latex Examination Gloves
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 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)
Shule M. Mupkey 12
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081990
§ 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.