(187 days)
An 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 examination glove
This document is a 510(k) clearance letter from the FDA for a medical device: "Regent Biogel Diagnostic Powder-Free Examination Glove with Protein Content Labeling Claim of 50 Micrograms or less".
This type of device (an examination glove) does not typically have acceptance criteria and a study to prove performance in the same way that a diagnostic algorithm or a complex medical instrument would. The clearance is based on substantial equivalence to predicate devices, and the "acceptance criteria" here relate to meeting regulatory standards and the specific protein content claim.
Therefore, many of the requested fields are not applicable to this document. I will fill in what can be inferred or directly stated.
Acceptance Criteria and Device Performance Study for Regent Biogel Diagnostic Powder-Free Examination Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to legally marketed predicate devices. | The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976. |
| Protein Content Labeling Claim: 50 Micrograms or less. | The device's trade name includes "with Protein Content Labeling Claim of 50 Micrograms or less." The FDA clearance implies this claim was substantiated for regulatory purposes. (Specific test results are not detailed in this letter.) |
| Compliance with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). | The device is cleared for marketing "subject to the general controls provisions of the Act." The FDA assumes compliance with the Quality System Regulation (21 CFR Part 820) which covers GMP. |
| Intended Use: Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner. | The "Indications for Use" explicitly state this purpose. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable for this 510(k) clearance letter. This document does not detail specific performance studies with test sets in the context of diagnostic or algorithmic performance. The clearance is based on substantial equivalence and regulatory compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is not evaluated by experts for "ground truth" in the diagnostic sense. The FDA's evaluation is by regulatory experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI-assisted device or a diagnostic device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of device is primarily based on:
- Regulatory Standards Compliance: Adherence to established FDA regulations (e.g., general controls, Quality System Regulation).
- Performance Benchmarking to Predicate Devices: Demonstrating that the device is as safe and effective as a legally marketed predicate device (which would have its own established performance characteristics, often related to physical properties like tensile strength, barrier integrity, and protein content).
- Manufacturer's Internal Testing: The manufacturer would have conducted tests to substantiate the protein content claim and other performance characteristics, which are reviewed by the FDA during the 510(k) process, but the detailed results are not in this letter.
8. The sample size for the training set
Not applicable. This is not a machine learning or diagnostic device that uses a "training set."
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Neil Anderson London International Group Incorporated 2926 Columbia Highway Dotham, Alabama 36303
OCT 2 9 1997
Re : K971514 Regent Biogel Diagnostic Powder-Free Trade Name: Examination Glove with Protein Content Labeling Claim of 50 Micrograms or less Requlatory Class: I Product Code : _ LYY _______ . October 21, 1997 Dated: Received: October 22, 1997
Dear Mr. Anderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any ebligation you might have under sections 531 -
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Page 2 - Mr. Anderson
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
U. Victurus
Timothy A. II atows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX II
Indications for Use
Applicant - London International Group (Regent Medical)
510(K) Number (if known) K971514
Device Name - Non-sterile examination glove)
Indications for use:
50 MICROGRAMS OR LESS "An examination glove is a disposable device intended for medical purposes
Regent Biogel Diagnostic Procedure With Protein Content Labeling Claim C
WDER-HR
that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
Concurrence of CDRH Office of Device Evaluation
Clins S. him
Prescription Use
OR Over the Counter X
Per 21 CFR 801.109
§ 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.