(42 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Nitrile Examination Gloves (Polymer Coated)
Here's an analysis of the provided text in relation to acceptance criteria and device study, based on the information available:
The provided document is a 510(k) clearance letter from the FDA for "Powderfree Nitrile Examination Gloves." It certifies that the device is "substantially equivalent" to legally marketed predicate devices.
Critical Point: The concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as typically understood in the context of AI/ML medical devices, or even complex non-AI medical devices with performance claims, is not directly applicable to this document.
This document pertains to a 510(k) submission for a Class I medical device (gloves), which is subject to "general controls provisions" and substantial equivalence to a predicate device. For such devices, the primary "study" is often demonstrating that the new device is as safe and effective as (i.e., substantially equivalent to) existing devices on the market, usually through a comparison of physical properties, materials, and intended use, rather than complex clinical studies or AI performance metrics.
Therefore, many of the requested fields about AI-specific studies, test sets, ground truth establishment, and expert adjudication are not present or relevant in this type of FDA clearance document for a simple Class I device.
However, I can extract what is available or inferable from the document in relation to your request, albeit with many "Not Applicable" entries.
Acceptance Criteria and Device Performance
Since this is a substantial equivalence determination for examination gloves, the "acceptance criteria" are implied to be that the gloves perform comparably to predicate devices in preventing contamination and are safe for their intended use. There are no explicit quantitative performance metrics or a detailed "study" described in the provided FDA letter itself. Instead, the FDA reviewed the manufacturer's 510(k) submission (which is not provided here) that would have contained data supporting substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from 510(k) Context for Examination Gloves) | Reported Device Performance (Implied / Inferred) |
|---|---|
| Substantial Equivalence to Predicate Devices | Device determined to be substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. (Based on FDA letter's core finding). |
| Meets General Controls Provisions of the Act | Manufacturer is expected to comply with annual registration, listing, good manufacturing practice (QSR), labeling, and prohibitions against misbranding and adulteration. |
| Prevents Contamination Between Patient and Examiner | Intended for medical purpose to prevent contamination; presumed to perform this function comparably to predicate devices. |
| Disposable | Stated as a "disposable device" in the Indications for Use. |
| Worn on Examiner's Hand or Finger | Stated in the Indications for Use. |
| Powderfree Nitrile Material (as per trade name) | Implied to perform as expected for powderfree nitrile gloves, comparable to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated in the FDA letter. For a Class I device like gloves, the "test set" would typically refer to the samples of gloves tested for physical properties (e.g., tensile strength, barrier integrity) and biocompatibility, as compared to predicate devices. The 510(k) submission (not provided) would contain this information.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is not an AI/ML device, nor does it typically involve expert review for "ground truth" in the way clinical diagnostic devices do. The FDA staff (e.g., those in the Division of Dental, Infection Control and General Hospital Devices) are the experts who reviewed the technical documentation for substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3. The 510(k) review process is an internal FDA regulatory review, not a clinical trial adjudication of medical cases.
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 a non-AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a non-AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this type of device, "ground truth" would relate to accepted industry standards for glove properties, material safety, and performance characteristics, typically established through laboratory testing rather than clinical "ground truth" labels.
8. The sample size for the training set:
- Not Applicable. This is a non-AI device.
9. How the ground truth for the training set was established:
- Not Applicable. This is a non-AI device.
Summary regarding the provided document:
The provided FDA letter is a regulatory clearance document based on "substantial equivalence" for a simple medical device (gloves). It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment relevant to complex medical devices, especially AI-driven ones. The "study" here refers to the manufacturer's submission demonstrating that their gloves are comparable to existing, legally marketed gloves, and thus are safe and effective for their intended use.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Mr. Lim Lee Aik Managing Director SRI Johani Sdn. Bhd. Lot PT 7178, Balakong N/V, 43300 Seri Kembangan Selangor Darul Malaysia
K974185 Re : Powderfree Nitrile Examination Gloves Trade Name: (Polymer Coated) Requlatory Class: I Product Code: LZA October 17, 1997 Dated: Received: November 6, 1997
Dear Mr. Lee Aik:
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 regulations 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 General regulation (21 CFR Part 820) and that, Devices: 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
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Page 2 - Mr. Lee Aik
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 diaqnostic 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 one regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to 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.fdf.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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Attachment 7
510(k) number (if known) : _ K 974185
Nitrile Examination Gloves Device Name: Coated vmer
Indications For Use:
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or contamination between patient and finger to prevent examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Qlin S. Lim
(Division Sign Off)
Division of Dantal, Infection Control and General Hospit 510(k) Number
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-3-95)
§ 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.