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510(k) Data Aggregation
(80 days)
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, blue colored nitrile gloves featuring an inner coating of hyaluronic acid and single use only. There are six different sizes- XS, S, M, L, XL and XXL. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs, opioid Fentanyl Citrate, simulated Gastric Acid and Xylazine per ASTM D6978-05.
The provided document is a 510(k) clearance letter from the FDA for Nitrile Powder-Free Exam Gloves. It details the device's characteristics, indications for use, and a comparison with predicate and reference devices, as well as a summary of non-clinical testing.
However, the nature of this medical device (examination gloves) means that the provided information does not include the typical "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device for diagnostic or prognostic purposes, which is what your questions #2 through #9 are geared towards.
For examination gloves, the "acceptance criteria" are based on physical properties, biocompatibility, and permeation resistance to certain chemicals, assessed through laboratory testing, not clinical studies involving patient data or expert interpretation.
Therefore, I will answer the questions that are applicable to the provided document and explicitly state when a question is not applicable.
Acceptance Criteria and Device Performance for Nitrile Powder-Free Exam Gloves
1. A table of acceptance criteria and the reported device performance
| Test Performed | Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Meet requirement inspection level G-I, AQL 2.5 (ISO2859-1) | Pass |
| Dimension - Length | ASTM D6319-19 | Minimum 220mm for size XS-S; Minimum 230mm for size M-XXL | Pass |
| Dimension - Width | ASTM D6319-19 | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| Dimension - Thickness | ASTM D6319-19 | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| Physical Properties (Tensile Strength) | ASTM D6319-19, ASTM D412-16 | Before and After Aging: 14 MPa Min | Pass |
| Physical Properties (Ultimate Elongation) | ASTM D6319-19, ASTM D412-16 | Before Aging: 500% Min; After Aging: 400% Min | Pass |
| Powder Residue | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass |
| Skin Irritation | ISO10993-23:2021 | Under the conditions of the study, not a primary skin irritant | Pass |
| Skin Sensitization | ISO10993-10:2021 | Under the conditions of the study, not a contact sensitizer | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Under the conditions of the study, no signs of acute systemic toxicity were observed | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 | Refer to the table below for specific drug breakthrough times. | Pass (met listed times) |
Chemotherapy and Other Drug Permeation Minimum Breakthrough Detection Times:
| Chemotherapy Drugs | Minimum Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | >240 min. |
| Carmustine, 3.3 mg/ml | 11.6 min. |
| Cisplatin, 1 mg/ml | >240 min. |
| Cyclophosphamide, 20 mg/ml | >240 min. |
| Cytarabine HCl 100 mg/ml | >240 min. |
| Dacarbazine, 10 mg/ml | >240 min. |
| Daunorubicin HCl, 5 mg/ml | >240 min. |
| Doxorubicin HCl, 2 mg/ml | >240 min. |
| Etoposide, 20 mg/ml | >240 min. |
| 5-Fluorouracil, 50 mg/ml | >240 min. |
| Gemcitabine HCl, 38 mg/ml | >240 min. |
| Idarubicin HCl, 1 mg/ml | >240 min. |
| Ifosfamide, 50 mg/ml | >240 min. |
| Irinotecan HCl, 20 mg/ml | >240 min. |
| Mechlorethamine HCl, 1 mg/ml | >240 min. |
| Melphalan HCl, 5 mg/ml | >240 min. |
| Methotrexate, 25 mg/ml | >240 min. |
| Mitomycin-C, 0.5 mg/ml | >240 min. |
| Mitoxantrone HCl, 2 mg/ml | >240 min. |
| Paclitaxel, 6 mg/ml | >240 min. |
| Thiotepa, 10 mg/ml | 25.3 min. |
| Vincristine Sulfate, 1 mg/ml | >240 min. |
| Fentanyl, Gastric Acid and Xylazine | Minimum Breakthrough Detection Time |
|---|---|
| Fentanyl Citrate Injection, 50mcg/ml | >240 min. |
| Simulated Gastric Acid | >240 min. |
| Fentanyl Citrate (50mcg/ml): Xylazine HCl (100mg/ml), 50:50 | >240 min. |
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 specify the exact sample sizes (e.g., number of gloves tested for each physical or chemical property) for the non-clinical tests. It only states that testing was conducted. Data provenance (e.g., country of origin, retrospective/prospective) is not provided as these are laboratory tests of a manufactured product, not data collected from patients.
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)
Not applicable. Ground truth for glove performance tests (physical properties, biocompatibility, chemical permeation) is established by adherence to standardized testing methodologies (e.g., ASTM, ISO standards) and measurable outcomes, not by expert consensus or interpretation in the way it is for diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies or similar diagnostic contexts where expert consensus is required for labeling data. This does not apply to the laboratory testing of gloves.
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 type of study is relevant for AI-powered diagnostic or screening tools that assist human interpreters. The device in question is examination gloves, which do not involve human readers interpreting cases or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product (gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on direct measurements and observations derived from standardized laboratory tests (e.g., tensile strength, elongation, hole detection, chemical permeation) defined by recognized industry standards (ASTM, ISO).
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI/ML algorithm.
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