(132 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant, proprietary coating (containg Chitosan, Provitamin B, Gluconolactone and Glycerol) and protein labeling claim (50 MICROGRAMS or Less)
The provided document describes the safety and effectiveness summary for Protegrity Sterile Latex/Nitrile Surgical Gloves. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Devices should be non-irritating. | Gloves are non-irritating. |
| Guinea Pig Maximization | Devices should not display potential for sensitization. | Gloves do not display any potential for sensitization. |
| Ultimate Elongation & Tensile Strength | Exceed requirements for rubber surgical gloves per ASTM D3577-01a2. | Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2. |
| Barrier Defects | Exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2. | Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2. |
| Powder Level | Meet powder level requirements for "Powder Free" designation. | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01. Results generated values below 2 mg of residual powder per glove. |
| Water extractable protein per gram | Less than 50 micrograms. | These latex gloves contain 50 micrograms or less of water extractable protein per gram. (This is mentioned in the description and indications for use, implying it is a key characteristic/criterion). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for barrier defects, number of guinea pigs for sensitization). The provenance of the data (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is typically not applicable to studies for surgical gloves, as the "ground truth" is established through standardized laboratory and biological tests rather than expert interpretation of medical images or patient data. The tests are defined by specific ASTM and CFR standards.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against established technical standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
Not applicable. This is a medical device for physical protection, not an AI-based diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is a medical device for physical protection, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on established industry standards and regulatory requirements. These include:
- ASTM International Standards: Specifically ASTM D3577-01a2 for ultimate elongation & tensile strength, and barrier defects; and ASTM D6124-01 for residual powder.
- Code of Federal Regulations (CFR): Specifically 21 CFR §800.20 for barrier defects.
- Biological Compatibility Standards: Implied for Primary Skin Irritation and Guinea Pig Maximization tests, demonstrating biocompatibility.
- Chemical/Analytical Standards: For water extractable protein content.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense. The "training" for the manufacturing process would be part of Good Manufacturing Practices (GMP) and quality control, but not a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an algorithm. For a physical medical device like surgical gloves, the "ground truth" or acceptable performance is established through adherence to the aforementioned ASTM and CFR standards during the development and manufacturing process.
§ 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).