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510(k) Data Aggregation
(28 days)
The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.
The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.
There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.
The materials and the manufacturing process technology are the same.
The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set or data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications for an AI/ML device.
- Adjudication method for an AI/ML device test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
- Standalone performance of an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set of an AI/ML device.
- How the ground truth for an AI/ML training set was established.
However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.
Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves
This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing of Gloves):
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Test | Length (mm): XS/S/M/L/XL/XXL: ≥230 | Pass |
| Width (mm): XS: 70±10mm; S: 85±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Pass | ||
| ASTM D5151-19 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTM D5151 | Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: 14MPa, min | Pass |
| Ultimate Elongation: 500% min | Pass | ||
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: 14MPa, min | Pass |
| Ultimate Elongation: 400% min | Pass | ||
| ASTM D6124 | Powder Content | Meet the requirements of Less than 2mg per glove | Pass |
| ASTM D6978-05 (2019) | Detect the Permeation time by Chemotherapy Drugs and Fentanyl of the glove | Meet the requirements of ASTM D6978-05. (Specific breakthrough times listed elsewhere in document) | Pass |
| ISO 10993-10 | Irritation and Sensitization | Non-irritating; Non-sensitizer | Under the conditions of the study, not an irritant and not a sensitizer |
| ISO 10993-5 | Cytotoxicity | Non Cytotoxic | Under conditions of the study, not cytotoxic |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
- Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device testing.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
- For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
- For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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