(137 days)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The powder free Nitrile Examination glove is a disposable Class 1 medical device made of Nitrile rubber, and is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The principal operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves for medical Application.
The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs" (K213306), a Class I medical device.
Note: The document is for a medical device (gloves), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study components for AI/SaMD (e.g., ground truth establishment by experts, MRMC studies, effect size of AI assistance, training set details) are not applicable or provided in this context. The information provided focuses on the physical and chemical performance of the gloves.
Here's an breakdown of the available information regarding acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criteria are based on various ASTM and ISO standards for examination gloves and chemotherapy drug permeation.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance and Results |
|---|---|---|---|
| ASTM D5151 | Water tightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Pass: Total 200 pcs of gloves were tested, 0 pcs rejected. |
| ASTM D6319 | Physical Dimensions Test | Length(mm): S: ≥220 mm; M/L/XL: ≥230 mm. | |
| Width(mm): S:80±10mm; M:95±10mm; L: 110±10mm; XL: 120±10mm. | |||
| Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Pass: 13 pcs each size, total 65 pcs of gloves were tested, 0 pcs rejected. | ||
| ASTM D412 | Physical properties (Tensile Strength & Ultimate Elongation) | Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500% | |
| After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500% | Pass: 13 pcs each size, total 65 pcs of gloves were tested, 0 pcs rejected. | ||
| ASTM D6124 | Residual Powder Content | Meet the requirements of ASTM D6124 240 minutes for most, with specific lower times for Carmustine and Thio Tepa) | |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | No explicit minimum acceptance criterion listed for Carmustine, but the reported value is a key performance metric. | 16.9 minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 minutes | >240 minutes |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 minutes | >240 minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | >240 minutes | >240 minutes |
| Eotoside (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 minutes | >240 minutes |
| Mechlorethamine | 1.0 mg/ml(1,000 ppm) | >240 minutes | >240 minutes |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 minutes | >240 minutes |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 minutes | >240 minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | No explicit minimum acceptance criterion listed for Thio Tepa, but the reported value is a key performance metric. | 22.6 minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 minutes | >240 minutes |
2. Sample sizes used for the test set and the data provenance
- ASTM D5151 (Water tightness): 200 pieces of gloves.
- ASTM D6319 (Physical Dimensions): 13 pieces for each size (total 65 pieces: S, M, L, XL, and presumably X-Small from the comparison table, although the specific breakdown adds up to 5 sizes * 13 = 65).
- ASTM D412 (Physical Properties): 13 pieces for each size (total 65 pieces).
- ASTM D6124 (Residual Powder Content): 5 pieces for each size (total 25 pieces).
- ISO 10993-10 (Skin irritation/sensitization) & ISO 10993-5 (Cytotoxicity): The specific number of test subjects (e.g., guinea pigs for sensitization, L929 cells for cytotoxicity) is not explicitly stated, but standard animal models and cell lines are typically used.
- ASTM D6978-05 (Chemotherapy Drug Permeation): The specific sample size for each drug permeation test is not explicitly stated in this summary. However, these are bench tests.
Data Provenance: The document does not specify the country of origin for the testing data beyond the manufacturer being in China. The tests are "Performance Testing (Bench)" and "Biocompatibility Testing," indicating they are laboratory-based studies. The nature of these tests means they are prospective in the sense that the testing was conducted specifically to evaluate the performance of these gloves against the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical medical glove and not an AI/Software as a Medical Device (SaMD) that would rely on expert interpretation of medical images or data for ground truth. The "ground truth" for these tests is the objective measurement against established physical/chemical standards (e.g., a hole detected by water, a specific tensile strength value, a chemical permeation time).
4. Adjudication method for the test set
This is not applicable. The tests are objective measurements against established standards, not subjective interpretations requiring reader 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
This is not applicable. This is a device (glove) that does not involve human readers interpreting data or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
The ground truth used for these studies is based on accepted international and national consensus standards for medical gloves and their performance (ASTM D5151, ASTM D6319, ASTM D412, ASTM D6124, ISO 10993-10, ISO 10993-5, and ASTM D6978-05). It is not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic medical device. It's objective measurement against defined physical and chemical criteria.
8. The sample size for the training set
This is 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
This is not applicable for the reasons stated above.
§ 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.