(83 days)
The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The device in this 510(k) submission is the Powdered Latex Surgical Gloves. Sterile which is made of natural rubber latex.
The provided text describes a 510(k) submission for "Powdered Latex Surgical Gloves, Sterile" and explicitly states that the only difference from the predicate device (Comfit Beaded Surgeon's Gloves, Powdered and Hypoallergenic, K951662) is the inclusion of an Expiration Date Labeling Claim. The submission focuses on demonstrating that the device maintains its properties over the claimed shelf-life.
Therefore, the acceptance criteria and study detailed are specifically about shelf-life stability, not a clinical performance study of the gloves in a medical context.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Parameters for Stability) | Reported Device Performance (Maintained for 5 years) |
|---|---|
| Barrier properties | Maintained |
| Physical properties | Maintained |
| Mechanical properties | Maintained |
| Packaging integrity | Maintained |
| Sterility | Maintained |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "results of stability study conducted on Powdered Latex Surgical Gloves, Sterile" but does not specify:
- The sample size used for the stability study (test set).
- The data provenance (e.g., country of origin, retrospective or prospective). However, it's inherently a prospective study by nature (stability studies track products over time).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to a shelf-life stability study. Ground truth in this context is established by laboratory testing against predefined specifications, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to samples from the stability study, and their performance is measured objectively rather than through adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is for comparing human performance (with or without AI assistance) in tasks like image interpretation, which is not relevant to the shelf-life stability of surgical gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (surgical gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the stability study is established by objective laboratory measurements and tests against established specifications for:
- Barrier properties (e.g., integrity, leak tests)
- Physical properties (e.g., dimensions, visual inspection)
- Mechanical properties (e.g., tensile strength, elongation, force at break)
- Packaging integrity (e.g., seal strength)
- Sterility (e.g., microbiological testing)
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).