(56 days)
A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.
The provided text describes the acceptance criteria and performance of the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves. No study proving the device meets the acceptance criteria is detailed in the submission; rather, the document declares that the device meets existing standards and requirements.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Requirement (Acceptance Criteria) | Reported Device Performance (New Device) | Study/Test Method |
|---|---|---|---|
| Material Composition | Not explicitly stated as a separate requirement, but defined. | Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 µg/dm2 or less (Tan) | N/A |
| Design | Single Use, Sterile, Powder-free, Hand Specific, Independent Thumb, Beaded Cuff, Lubricated | Meets design requirements | N/A |
| Intended Use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove | N/A |
| Dimensions | Meets ASTM D3577 | Meets requirements | ASTM D3577 |
| Physical Properties | Meets ASTM D3577 | Meets requirements | ASTM D3577 |
| Freedom from Holes | AQL meets 21CFR 800.20 & ASTM D3577 requirements | Meets requirements | 21CFR 800.20, ASTM D3577 |
| Powder Residual | ≤ 2.0 mg/glove for Powder-Free designation per ASTM D3577 | Meets requirements | ASTM D3577 (tested using ASTM standard D6124) |
| Protein Content | Less than 50 µg/dm2 of total water extractable protein per glove (as tested per ASTM D5712) | Contains less than 50 µg/dm2 of total water extractable protein per glove | ASTM D5712, FDA Medical Glove Guidance Manual |
| Biocompatibility | ISO 10993-1 | Meets requirements | ISO 10993-1, ISO 10993-10 |
| Primary Skin Irritation | ISO 10993-10 | Pass | ISO 10993-10 |
| Guinea Pig Maximization | ISO 10993-10 | Pass | ISO 10993-10 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each test (e.g., for physical properties, protein content, or biocompatibility). It states that testing was performed according to specific ASTM and ISO standards, which would imply certain sample size requirements within those standards. However, the specific numbers are not reported.
The data provenance is not explicitly stated in terms of country of origin, nor is it explicitly labeled as retrospective or prospective. It is implied to be data collected as part of the device's development and testing for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the device described. The device is a surgical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO, CFR) rather than against expert-established ground truth in a diagnostic or interpretive sense. The "ground truth" here is the adherence to these published standards.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or assessment is involved (e.g., medical image reading). Since this submission concerns a physical medical device (surgical gloves) and its compliance with technical standards, such adjudication methods are not relevant or described. The tests are objective measurements against defined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or interpretive devices where human readers are involved. For surgical gloves, the evaluation focuses on meeting predefined physical and biochemical standards.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a physical product, not an algorithm, so a standalone study in this context is irrelevant.
7. Type of Ground Truth Used
The "ground truth" used is defined by adherence to established industry and regulatory standards. Specifically:
- ASTM D3577 (for dimensions, physical properties, freedom from holes, powder residual)
- 21 CFR 800.20 (for AQL in freedom from holes)
- ASTM D6124 (for testing powder residual)
- ASTM D5712 (for protein content)
- FDA Medical Glove Guidance Manual (for protein content)
- ISO 10993-1 (for biocompatibility)
- ISO 10993-10 (for primary skin irritation and guinea pig maximization)
8. Sample Size for the Training Set
Not applicable. This device is a physical medical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).