(143 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time,
0.01 µg/cm²/minute |
|-----|-------------------------------------|------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10 mg/ml) | 40.3 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |
WARNING: Do not use with Carmustine (BCNU) (3.3 mg/m1)
CAUTION: Testing showed an average breakthrough time of 40.3 minutes with Thiotepa (10 mg/ml).
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene and neoprene, which are synthetic rubber latex. The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.
Please find the requested information regarding the acceptance criteria and study details below.
1. Table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Meets requirements |
| Primary Skin Irritation | ISO 10993-10 | Non-irritating, under the conditions of the study |
| Guinea Pig Maximization (Sensitization) | ISO 10993-10 | Non-sensitizing, under the conditions of the study |
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements |
| Freedom from Holes | 21CFR800.20, ASTM D3577 | Meets requirements (AQL 1.5) |
| Chemotherapy Drug Permeation (ASTM D6978) | Varies by drug | - Carmustine (BCNU) (3.3 mg/ml): 17.9 minutes (WARNING: Do not use with this drug) |
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (20 mg/ml): >240 minutes
- Doxorubicin HCl (2.0 mg/ml): >240 minutes
- Etoposide (Toposar) (20 mg/ml): >240 minutes
- Fluorouracil (50 mg/ml): >240 minutes
- Methotrexate (25 mg/ml): >240 minutes
- Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes
- Thiotepa (10 mg/ml): 40.3 minutes (CAUTION: Testing showed an average breakthrough time of 40.3 minutes)
- Vincristine Sulfate (1.0 mg/ml): >240 minutes |
| Powder Residual | ASTM D3577 (≤2.0 mg/glove) | Meets requirements (≤2.0 mg/glove for Powder-Free designation) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for permeation, how many samples for biocompatibility). However, it indicates compliance with standards like ASTM D3577 and ASTM D6978, which would inherently dictate minimum sample sizes for their respective tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The tests are reported as "conducted for determination of substantial equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical glove, and the "ground truth" for its performance is established through standardized laboratory tests (e.g., chemical permeation, physical properties) as per ASTM and ISO standards, not through expert consensus on interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable. As noted above, performance is determined by objective laboratory measurements against established standards, not through adjudication of expert opinions.
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 a medical device (surgical glove), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on objective measurements and results from standardized laboratory tests according to recognized industry standards (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D3577 for physical properties, ISO 10993 for biocompatibility).
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant 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).