(257 days)
The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
Motex Powdered Nitrile Surgical Gloves are made of synthetic rubber. They are sterilized by radiation, and intended to be used in surgery to prevent the cross contamination between patient and user.
This is a medical device submission for a surgical glove, not an AI/ML powered device. As such, the requested information regarding AI/ML study design and performance criteria is not applicable.
The device, Motex Powdered Nitrile Surgical Gloves, is seeking substantial equivalence to a predicate device (NUZONE Nitrile Powdered Surgical Gloves) based on meeting established performance standards for surgical gloves.
Here's a breakdown of the requested information, adapted for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
This device's performance is demonstrated by meeting recognized industry standards.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D3577-09e1 | Meets ASTM D3577-09 |
| Physical Properties | ASTM D3577-09e1 | Meets ASTM D3577-09 |
| Freedom from Holes | ASTM D3577-09e1 | Meets ASTM D3577-09 |
| Water leak testing | ASTM D5151-06 | Meets ASTM D3577-09 (Implied by meeting D3577-09 which includes this) |
| Residual powder testing | ASTM D6124-06 | Results generated values below 15mg/dm² of residual powder per glove (Meets standard) |
| Water extractable protein testing | ASTM D5712-10 | Meets ASTM D5712-10 |
| Biocompatibility | ISO 10993-10:2010 | Meets ISO 10993-10:2010 |
| ISO 10993-12:2007 | Meets ISO 10993-12:2007 | |
| Sterilization Validation | ISO 11137-1:2006 | Meets ISO 11137-1:2006 |
| ISO 11137-2:2006 | Meets ISO 11137-2:2006 | |
| Skin Sensitization Test | (Part of ISO 10993-10) | Not a sensitizer |
| Skin Irritation Test | (Part of ISO 10993-10) | Not an irritant |
2. Sample size used for the test set and the data provenance
The document specifies performance testing against ASTM and ISO standards. These standards typically specify their own sampling plans and test methodologies. The document does not provide the specific sample sizes used for each test (e.g., number of gloves tested for pinholes, physical properties).
- Data Provenance: The tests were conducted by the manufacturer, Shanghai Motex Healthcare Co., Ltd. (China). The document does not explicitly state whether the tests were retrospective or prospective, but based on the context of a 510(k) submission, they would typically be prospective tests performed on representative samples of the manufactured devices to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable for this type of medical device. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) often associated with AI/ML systems. For surgical gloves, compliance with physical, chemical, and biological standards is determined by laboratory testing and measurements, not by expert consensus on an "answer."
4. Adjudication method for the test set
Not applicable for this type of medical device. Adjudication methods like 2+1 or 3+1 refer to how multiple expert opinions are resolved to establish a single "ground truth," which is not relevant for objective laboratory measurements against predefined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, this was not done. MRMC studies are specific to evaluating the diagnostic performance of readers (human or AI) on cases, particularly in imaging, and are not relevant for the evaluation of a surgical glove's physical and biological properties. There is no "human reader" component in assessing a surgical glove's compliance with ASTM/ISO standards.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical glove, not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies here.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective, quantitative measurements and laboratory tests defined within internationally recognized standards (ASTM, ISO). For example:
- Physical properties (e.g., tensile strength, elongation): Measured values are compared against minimum/maximum thresholds specified in ASTM D3577-09.
- Freedom from holes: Determined by water leak testing (ASTM D5151-06), where the "ground truth" is whether a glove leaks or not under specified pressure for a given duration.
- Residual powder: Measured directly and compared against the 15mg/dm² threshold from ASTM D6124-06.
- Biocompatibility: Determined by the results of specific in-vitro and in-vivo tests (e.g., skin irritation, sensitization) that follow ISO 10993 series standards, where the "ground truth" is the observation of a biological response (or lack thereof) compared to control or reference materials.
- Sterilization: Validated by adherence to ISO 11137 series standards, ensuring a specified sterility assurance level (SAL).
8. The sample size for the training set
Not applicable. This device is not an AI/ML system, so there is no concept of a "training set" in the machine learning sense. The device is manufactured according to specifications and then tested against standards, not "trained" on data.
9. How the ground truth for the training set was established
Not applicable for the same reasons as #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).