(70 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED A FATIENT EXAMINATION ODD THE EXAMINER'S HAND OR SEARCH AND FOR MEDIOAL POR! OUD OF AND AND ATION BETWEEN PATIENT AND EXAMINER.
Disposable Vinyl Exam Glove, Powder Free
This document is a 510(k) premarket notification decision letter from the FDA for a Disposable Vinyl Exam Glove, Powder Free. It is not a study report for an AI/ML medical device. Therefore, most of the requested information about acceptance criteria and study details for an AI/ML device is not present in this document.
However, I can extract the safety and performance tests that would typically be required for such a device and what a "study" for this type of device would generally entail.
Here's an interpretation based on the standard requirements for patient examination gloves:
1. A table of acceptance criteria and the reported device performance
For examination gloves, the "acceptance criteria" and "device performance" are typically defined by recognized consensus standards. A 510(k) submission for a glove would include test reports demonstrating compliance with these standards. The document provided does not contain a table of acceptance criteria or reported device performance. However, typical acceptance criteria for examination gloves include:
| Test/Characteristic | Acceptance Criteria (Example) | Reported Device Performance (Not within this document) |
|---|---|---|
| Physical (ASTM D5250) | ||
| Tensile Strength (before aging) | ≥ 9 MPa (median) | (Would be provided in a test report) |
| Tensile Strength (after aging) | ≥ 9 MPa (median) | (Would be provided in a test report) |
| Elongation (before aging) | ≥ 300% (median) | (Would be provided in a test report) |
| Elongation (after aging) | ≥ 300% (median) | (Would be provided in a test report) |
| Barrier Integrity (ASTM D5151) | ||
| Water Leak Test (AQL) | 1.5% for critical defects (Pinholes) | (Would be provided in a test report) |
| Biocompatibility (ISO 10993) | ||
| Cytotoxicity | Non-cytotoxic | (Would be provided in a test report) |
| Sensitization | Non-sensitizing | (Would be provided in a test report) |
| Irritation | Non-irritating | (Would be provided in a test report) |
| Labeling | Compliant with 21 CFR Part 801 (e.g., sterilization status) | (Reviewed by FDA for compliance) |
2. Sample size used for the test set and the data provenance
- Sample Size: For physical and barrier integrity tests, sample sizes are typically specified by the relevant ASTM standards (e.g., ASTM D5250, ASTM D5151). For example, water leak tests often require a statistically significant number of gloves from multiple batches. This information is not in the provided document, but would be in the detailed test reports submitted with the 510(k).
- Data Provenance: The tests are conducted according to recognized international or national standards. The data provenance would be the test labs (internal or external to the manufacturer) that performed the tests. This information is not in the provided document. Such tests are usually performed on a prospective basis (i.e., on manufactured batches specifically for testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device. "Experts" for establishing ground truth are relevant for AI/ML devices where human interpretation is the gold standard (e.g., radiologists for medical images). For examination gloves, performance is measured objectively through standardized physical, chemical, and biological tests, not subjective expert assessment.
4. Adjudication method for the test set
This question is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in AI/ML studies.
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
This question is not applicable to this type of device. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. Examination gloves are a physical barrier device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this type of device. "Standalone performance" refers to the algorithm's performance without human interaction, which is relevant for AI/ML software.
7. The type of ground truth used
For examination gloves, the "ground truth" is established through:
- Performance against defined standard specifications: e.g., a glove must achieve a certain tensile strength or elongation as per ASTM D5250.
- Absence of defects: e.g., a glove must not leak when tested according to ASTM D5151.
- Biocompatibility: e.g., the materials must not cause a toxic, irritating, or sensitizing reaction based on ISO 10993 tests.
This "ground truth" is objective and measured, not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.
8. The sample size for the training set
This question is not applicable to this type of device. "Training set" refers to data used to train an AI/ML algorithm.
9. How the ground truth for the training set was established
This question is not applicable to this type of device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Full Synergy Medical Products Incorporated C/O Ms. Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California 91739
MAR - 2 2012
Re: K113797
Trade/Device Name: Disposable Vinyl Exam Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 20, 2011 Received: December 23, 2011
Dear Ms. Deng:
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- Ms. Deng
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), 1 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,
Anthony D. Watson, BS, MS, MBA 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 Statement
| Applicant: | FULL SYNERGY MEDICAL PRODUCTS INC. |
|---|---|
| ------------ | ------------------------------------ |
510(k) Number (if known): APPLIED
K 113797
Device Name: Disposable Vinyl Exam Glove, Powder Free
Indications for Use:
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED A FATIENT EXAMINATION ODD THE EXAMINER'S HAND OR SEARCH AND FOR MEDIOAL POR! OUD OF AND AND ATION 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 1
Eli.kett S. Clavire-Willin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113797
§ 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.