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510(k) Data Aggregation
(128 days)
This powder-free 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 m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured using exact same material used in the currently cleared device, Esteem SMT glove (K093300) that has been legally marketed by Cardinal Health. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.
The provided document describes the safety and effectiveness summary for "Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs." This is for a medical device and not an AI or software device, therefore, the requested information elements related to AI/algorithm performance studies like sample size for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.
The acceptance criteria and the study proving the device meets these criteria are related to the physical, chemical, and biological properties of the surgical gloves.
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (New Device - K110272) |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. (Pass) |
| Guinea Pig Maximization | ISO 10993-10 | Gloves do not display any potential for sensitization. (Pass) |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 | Meet requirements |
| Physical Properties | ASTM D3577 | Meet requirements for rubber surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 | Tested in accordance with ASTM D5151 with acceptable results. Meets requirements. |
| Powder Residual | ASTM D3577 tested using ASTM D6124 | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values < 2mg of residual powder per glove. |
| Chemotherapy Drug Permeation: | ASTM D6978 | Under the test conditions prescribed by the test, the minimum normalized breakthrough detection times for each of the 25 chemotherapy drugs tested exceeded the maximum testing time of 240 minutes, except for Carmustine (BCNU) (3.3 mg/ml) and Thiotepa (10 mg/ml), which showed permeation time of less than 30 minutes (specifically, 0.37 min and 0.44 min respectively). This indicates the gloves are not protective against these two specific drugs for extended periods. |
| Chemotherapy Drug Permeation (Detailed values) | Minimum Breakthrough Detection Time (0.01 µg/cm²/min) > 240 minutes for acceptable protection (implied by the majority of test results). | Blenoxane (15 mg/ml): >240 min Busulfan (6 mg/ml): >240 min Carmustine (BCNU) (3.3 mg/ml): 0.37 min Cisplastin, (1.0 mg/ml): >240 min Cytarabine (100 mg/ml): >240 min Cyclophosphamide (20 mg/ml): >240 min Dacarbazine (10 mg/ml): >240 min Doxorubicin HCl (2.0 mg/ml): >240 min Ellence (25 mg/ml): >240 min Etoposide (Toposar) (20 mg/ml): >240 min Fludarabine (25 mg/ml): >240 min Fluorouracil (50 mg/ml): >240 min Idarubicin (1 mg/ml): >240 min Ifosfamide (50 mg/ml): >240 min Mechlorethamine HCl (1 mg/ml): >240 min Melphalan (5 mg/ml): >240 min Methotrexate (25 mg/ml): >240 min Mitoxantrone (2 mg/ml): >240 min Mitomycin C (0.5 mg/ml): >240 min Paclitaxel (Taxol) (6.0 mg/ml): >240 min Paraplatin (10 mg/ml): >240 min Rituximab (10 mg/ml): >240 min Thiotepa (10 mg/ml): 0.44 min Trisenox (0.1 mg/ml): >240 min Vincristine sulfate (1 mg/ml): >240 min |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for holes, or how many samples for biocompatibility). However, the tests were conducted according to recognized international and national standards (e.g., ISO 10993, ASTM D3577, ASTM D6978, 21 CFR 800.20), which typically specify appropriate sample sizes and methodologies.
The "data provenance" for this type of device (surgical gloves) would relate to the manufacturing and testing environment, not patient data. The tests are non-clinical, laboratory-based studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For surgical glove testing, "ground truth" is established by adherence to standardized test methods and criteria defined by organizations like ASTM and ISO, not by expert human consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or for AI output evaluation. The tests performed for these gloves (e.g., physical properties, chemical permeation) are objective laboratory measurements, not requiring adjudication.
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 device is a physical medical glove, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove, not an AI or algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective laboratory measurements and adherence to predefined specifications and test standards. For example:
- Biocompatibility: Determined by standardized in-vivo (e.g., guinea pig maximization) and in-vitro tests following ISO 10993.
- Physical Properties: Measured against specifications in ASTM D3577.
- Freedom from Holes: Determined by testing according to ASTM D5151 and meeting AQL (Acceptable Quality Level) requirements specified in 21 CFR 800.20 & ASTM D3577.
- Powder Residual: Measured using ASTM D6124 to meet ASTM D3577 limits.
- Chemotherapy Drug Permeation: Measured as breakthrough time using ASTM D6978.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
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