(260 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
The following drugs and concentration had NO breakthrough detected up to 240 minutes:
- Bendamustine HCl (5 mg/mL)
- Bleomycin Sulfate (15 mg/mL)
- Busulfan (6 mg/mL)
- Carboplatin (10 mg/mL)
- Carfilzomib (2 mg/mL)
- Cetuximab (Erbitux) (2 mg/mL)
- Chloroquine (50 mg/mL)
- Cisplatin (1 mg/mL)
- Cladribine (1 mg/mL)
- Cyclophosphamide (20 mg/mL)
- Cyclosporin A (100 mg/mL)
- Cytarabine HCl (100 mg/mL)
- Cytovene (10 mg/mL)
- Dacarbazine (10 mg/mL)
- Daunorubicin HCl (5 mg/mL)
- Decitabine (5 mg/mL)
- Docetaxel (10 mg/mL)
- Doxorubicin HCl (2 mg/mL)
- Epirubicin HCl (2 mg/mL)
- Etoposide (20 mg/mL)
- Fludarabine Phosphate (25 mg/mL)
- Fluorouracil (50 mg/mL)
- Fulvestrant (50 mg/mL)
- Gemcitabine HCl (38 mg/mL)
- Idarubicin HCl (1 mg/mL)
- Ifosfamide (50 mg/mL)
- Irinotecan HCl (20 mg/mL)
- Mechlorethamine HCl (1 mg/mL)
- Melphalan HCl (5 mg/mL)
- MESNA (100 mg/mL)
- Methotrexate (25 mg/mL)
- Mitomycin C (0.5 mg/mL)
- Mitoxantrone HCl (2 mg/mL)
- Oxaliplatin (2 mg/mL)
- Paclitaxel (6 mg/mL)
- Pemetrexed (25 mg/mL)
- Propofol (10 mg/mL)
- Raltitrexed (0.5 mg/mL)
- Retrovir (10 mg/mL)
- Rituximab (10 mg/mL)
- Temsirolimus (25 mg/mL)
- Topotecan HCl (1 mg/mL)
- Triclosan (1 mg/mL)
- Trisenox (Arsenic Trioxide) (1 mg/mL)
- Velcade (Bortezomib) (1 mg/mL)
- Vidaza (Azacitidine) (25 mg/mL)
- Vinblastine Sulfate (1 mg/mL)
- Vincristine Sulfate (1 mg/mL)
- Vinorelbine Tartrate (10 mg/mL)
- Zoledronic Acid (0.8 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:
- Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
- Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes
Warning: Not recommended for use with Carmustine and Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100mcg/2mL)
- Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid.
The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.
The provided FDA 510(k) clearance letter and summary concern a medical device, "Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid." This document details the product's attributes, testing, and comparison to a predicate device for regulatory clearance.
However, the questions you've asked (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training set details) are highly specific to the performance of an AI/ML medical device rather than a physical product like examination gloves. The provided document describes the physical and chemical performance of the gloves (e.g., resistance to permeation by chemotherapy drugs, physical properties, biocompatibility, and skin sensitization), not the performance of an artificial intelligence or machine learning algorithm.
Therefore, many of your questions are not applicable to the information contained within this 510(k) clearance for medical gloves. I will answer the applicable questions based on the provided text, and explicitly state when a question is not relevant to this type of device.
Acceptance Criteria and Device Performance for Nitrile Examination Gloves
The "acceptance criteria" for these gloves are primarily physical, chemical, and biological performance standards, as demonstrated through various ASTM and ISO tests. The "reported device performance" indicates whether the gloves met these pre-defined standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Requirement) | Reported Device Performance (Result) |
|---|---|
| Physical Properties (ASTM D6319-19): | |
| - Tensile strength (Before Aging): min 14 MPa | Pass |
| - Ultimate elongation (Before Aging): min 500% | Pass |
| - Tensile strength (After Aging): min 14 MPa | Pass |
| - Ultimate elongation (After Aging): min 400% | Pass |
| Dimensions (ASTM D6319-19): | |
| - Length: XS: min 220mm, S: min 220mm, M: min 230mm, L: min 230mm, XL: min 230mm, XXL: min 230mm | Pass |
| - Palm Width: XS: 70 ± 10mm, S: 80 ± 10mm, M: 95 ± 10mm, L: 110 ± 10mm, XL: 120 ± 10mm, XXL: 130 ± 10mm | Pass |
| - Thickness (Finger): min 0.05mm | Pass |
| - Thickness (Palm): min 0.05mm | Pass |
| Watertight Test (Freedom from Holes - ASTM D5151-19): | Pass Inspection Level G1, AQL 2.5 |
| Residual Powder Content (ASTM D6124-06): | Residual powder |
§ 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.