(97 days)
A powder-free 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.
POWDER-FREE NITRILE GLOVES, BLACK
This is a 510(k) premarket notification for "Powder-Free Nitrile Gloves, Black," which are Class I medical devices (patient examination gloves). The provided document is a substantial equivalence determination letter from the FDA.
Since this document is for a Class I medical device (gloves) and not an AI/ML-powered diagnostic device, many of the requested fields (such as those related to AI model performance, training sets, expert review, MRMC studies, etc.) are not applicable. The traditional "device performance" in this context refers to physical and chemical properties of the gloves, not accuracy in diagnostic tasks.
Here's the closest representation based on the information provided and typical requirements for such devices:
Acceptance Criteria and Study for Powder-Free Nitrile Gloves, Black
1. A table of acceptance criteria and the reported device performance
For patient examination gloves, key performance criteria typically relate to barrier integrity, physical properties, and biocompatibility. While the specific test results are not in this FDA letter, the substantial equivalence determination implies that the device met these criteria, likely by showing equivalence to a predicate device that has demonstrated compliance.
| Acceptance Criteria (Typical for Examination Gloves) | Reported Device Performance (Implied by Substantial Equivalence to Predicate) |
|---|---|
| Barrier Integrity | |
| Tensile Strength | Met or exceeded predicate device performance |
| Elongation at Break | Met or exceeded predicate device performance |
| Freedom from Holes and Leaks (AQL) | Met or exceeded predicate device performance (e.g., AQL 2.5 for water leak) |
| Physical Properties | |
| Dimensions (Length, Palm Width, Thickness) | Within specified range |
| Biocompatibility | |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritating |
Note: The FDA letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means that the new device performs at least as well as a legally marketed predicate device. The actual detailed test results demonstrating this equivalence are usually contained within the 510(k) submission itself, not in the FDA's final decision letter.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this document. For physical and chemical testing of gloves, sample sizes are typically defined by international standards (e.g., ISO, ASTM) and involve statistical sampling from manufacturing lots.
- Data Provenance: Not specified, but generally refers to data obtained from laboratory testing of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical product (glove), not a diagnostic device requiring expert interpretation for ground truth. Testing involves laboratory personnel following established protocols.
4. Adjudication method for the test set
- Not Applicable. No human interpretation or adjudication in the context of diagnostic tasks is involved. Testing relies on objective measurements.
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 diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used
- Objective Measurement/Standard Specifications: "Ground truth" for examination gloves typically comes from meeting defined physical, chemical, and biological specifications outlined in recognized standards (e.g., ASTM D6319 for Nitrile Examination Gloves, ISO 10993 for biocompatibility). For example, "freedom from holes" is assessed by a water leak test, and tensile strength by a materials testing machine.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of a manufactured physical product like a glove, as it doesn't involve machine learning or diagnostic image analysis.
9. How the ground truth for the training set was established
- Not Applicable.
§ 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.