(19 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.
The provided text describes the regulatory filing (510(k) Premarket Notification) for a "Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)". This document is for a medical device (a glove), not an AI/Software as a Medical Device (SaMD) or an algorithm. Therefore, the questions related to AI/algorithm performance metrics (such as MRMC studies, standalone algorithm performance, AI assistance effect size, training set sample size, expert ground truth establishment for AI data) are not applicable to this submission.
The acceptance criteria and device performance for this physical medical device are related to its material properties, physical dimensions, and resistance to chemotherapy drugs, as outlined by various ASTM and ISO standards.
Here's the information extracted and formatted according to the request, with clarification where the questions are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL: ≥230 | |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | |||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length: > 230 (Pass) | ||
| Width: XS: 72-74; S: 80-83; M: 95-98; L: 110-114; XL: 118-121 (Pass) | |||
| Thickness (mm): | |||
| XS: Finger: 0.07-0.10, Palm: 0.08-0.10 | |||
| S: Finger: 0.08-0.11, Palm: 0.08-0.11 | |||
| M: Finger: 0.08-0.12, Palm: 0.07-0.11 | |||
| L: Finger: 0.08-0.12, Palm: 0.08-0.11 | |||
| XL: Finger: 0.08-0.12, Palm: 0.08-0.12 (Pass) | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | XS: 2/125 leaks |
| S: 0/125 leaks | |||
| M: 0/125 leaks | |||
| L: 1/125 leaks | |||
| XL: 0/125 leaks (Pass) | |||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 240 minutes for most drugs, 22.0 minutes for Carmustine, 59.2 minutes for Thio Tepa) | Carmustine (BCNU) 3.3 mg/ml: 22.0 Minutes |
| Cisplatin 1.0 mg/ml: > 240 Minutes | |||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||
| Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes | |||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | |||
| Etoposide 20.0 mg/ml: > 240 Minutes | |||
| Fluorouracil 50.0 mg/ml: > 240 Minutes | |||
| Methotrexate 25 mg/ml: > 240 Minutes | |||
| Mitomycin C 0.5 mg/ml: > 240 Minutes | |||
| Paclitaxel 6.0 mg/ml: > 240 Minutes | |||
| Thio Tepa 10.0 mg/ml: 59.2 Minutes | |||
| Vincristine Sulfate 1.0 mg/ml: > 240 Minutes (All these values met the specified criteria for each drug) | |||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
2. Sample Size used for the test set and the data provenance:
- The reported results for physical and chemical resistance tests seem to be based on representative samples from production, as per the respective ASTM and ISO standards. The specific sample sizes for each test are implicitly defined by these standard test methods (e.g., ASTM D5151 for watertightness mentions testing 125 gloves per batch/size for AQL).
- Data provenance: Not explicitly stated, however, the manufacturer is Inner Mongolia Cureguard Medical Technology Co.,Ltd. (China), suggesting the testing was likely conducted in China or by labs compliant with international standards, possibly in China or elsewhere. The tests are "non-clinical" bench tests, not involving human data or patient populations. The data is retrospective in the sense that it's generated from manufactured product batches for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the device is a physical medical glove, and its performance and safety are assessed through objective laboratory tests governed by international standards (ASTM, ISO), not through expert interpretation of medical images or other data that would require a "ground truth" established by experts in a clinical context. The "ground truth" here is the result of standardized material science and chemical permeation testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring human adjudication for data interpretation.
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 physical medical device, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for the device's performance is established by the specified international standard test methods (ASTM and ISO standards) for physical properties, chemical resistance, and biocompatibility. For example, for watertightness, the ground truth is the absence of leaks when tested according to ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time and the specific drug concentration in the testing apparatus according to ASTM D6978. For biocompatibility, it's the observed biological response to testing protocols defined in ISO 10993-5 and ISO 10993-10.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.