(69 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 2.03 min. |
| Thiotepa | 25.23 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes. |
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
The provided text describes a 510(k) premarket notification for "Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". This is a medical device approval application, not a study of an AI/ML device. Therefore, the specific questions related to AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable.
However, I can extract the acceptance criteria and performance data for this device as it relates to the non-clinical tests conducted.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established by recognized standards like ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, and 16CFR 1500.41/1500.3. The "Performance Results" column indicates if the device meets these standards.
| Characteristics | Applicable Recognized Standards | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a (2005)e1 | Meets |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Meets |
| Freedom from holes | (FDA Pinhole requirements) | Meets |
| Residual Powder Test | ASTM D 6319-00a (2005)e1, ASTM D6124-06 | Meets |
| Primary Skin Irritation and Skin Sensitization | ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3 | Meets |
| Resistance to Permeation (Chemotherapy Drugs) | ASTM D6978-05 | See specific breakthrough detection times below |
Breakthrough Detection Times (BDT) for Chemotherapy Drugs (Resistance to Permeation):
| Chemotherapy Drug | Average BDT |
|---|---|
| Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 2.03 min. |
| Thiotepa | 25.23 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
Important Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes." This implies that while the device was tested against these drugs, their low BDTs are a critical factor for users to consider, and the labeling states "Do not use with Carmustine and Thiotepa."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each non-clinical test (e.g., how many gloves were tested for dimensions, physical properties, or permeation). It mentions the tests were performed by Syntex Healthcare Products Co., Ltd in China (the submitter's location), so the data likely originates from China. The tests are non-clinical and would be considered prospective for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are designed for AI/ML device evaluations. The presented document describes a traditional medical device (examination gloves) and its non-clinical testing. Therefore, these questions are not applicable to this submission. The "ground truth" for this device is determined by physical and chemical testing against established standards (e.g., ASTM standards for glove properties and permeation resistance). No AI/ML components are mentioned or evaluated in this 510(k) summary.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.