(110 days)
Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
Busulfan, 6 mg/ml (6,000 ppm)
Carboplatin /Paraplatin, 10 mg/ml (10,000 ppm)
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm)
Cytarabine HCI, 100 mg/ml (100,000 ppm)
Dacarbazine, 10.0 mg/ml (10,000 ppm)
Docetaxel, 10 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Ifosfamide, 50 mg/ml (50,000 ppm)
Mechlorethamine HCI, 1 mg/ml (1,000 ppm)
Methotrexate, 25 mg/ml (25,000 ppm)
Mitomycin, 0.5 mg/ml (500 ppm)
Mitoxantrone, 2 mg/ml (2,000 ppm)
Paclitaxel, 6.0 mg/ml (6,000 ppm)
Vincristine Sulfate, 1 mg/ml (1,000 ppm)
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes
WARNING: Do not use Carmustine and Thiotepa
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
This document describes the acceptance criteria and performance of "Disposable Medical Nitrile Examination Gloves (Non sterile)" (K212639).
This medical device is a Class I device and does not involve AI or human interpretation of medical images. Therefore, many of the requested categories in the prompt are not applicable. The information provided is based on the provided FDA 510(k) summary, which focuses on physical, chemical, and biological testing as per relevant ASTM and ISO standards for examination gloves.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | ||
| Size Small | Width: 80 mm ± 10mm | ||
| Length: 220 mm (Minimum) | |||
| Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05 mm (Minimum) | Width: 82mm-89mm | ||
| Length: 230mm (Minimum) | |||
| Thickness: Finger 0.12mm (Minimum), Palm 0.08mm (Minimum) | |||
| Passed | |||
| Size Medium | Width: 95 mm ± 10mm | ||
| Length: 230 mm (Minimum) | |||
| Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05 mm (Minimum) | Width: 91mm-96mm | ||
| Length: 240mm (Minimum) | |||
| Thickness: Finger 0.13mm (Minimum), Palm 0.08mm (Minimum) | |||
| Passed | |||
| Size Large | Width: 110 mm ± 10mm | ||
| Length: 230 mm (Minimum) | |||
| Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05 mm (Minimum) | Width: 111mm-113mm | ||
| Length: 240mm (Minimum) | |||
| Thickness: Finger 0.13mm (Minimum), Palm 0.09mm (Minimum) | |||
| Passed | |||
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Acceleration Aging: Tensile Strength (MPa): 14 (Minimum), Ultimate Elongation (%): 500 (Minimum) | |
| After Acceleration Aging: Tensile Strength (MPa): 14 (Minimum), Ultimate Elongation (%): 400 (Minimum) | Before Acceleration Aging: Tensile Strength (MPa): 29 (Minimum), Ultimate Elongation (%): 515 (Minimum) | ||
| After Acceleration Aging: Tensile Strength (MPa): 26 (Minimum), Ultimate Elongation (%): 511 (Minimum) | |||
| Passed | |||
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | (Mean) AQL 2.5 | Passed |
| ASTM D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | ≤ 2.0 mg/glove | 0.2 mg/glove, Passed |
| ASTM D6978-05 Testing with Chemotherapy Drugs | To assess resistance to permeation by chemotherapy drugs | No breakthrough detected up to 240 minutes for specified drugs; permeation times for Carmustine and Thiotepa noted as less than 60 minutes. | No breakthrough detected up to 240 minutes for: Busulfan, Carboplatin /Paraplatin, Cisplatin, Cyclophosphamide (Cytoxan), Cytarabine HCI, Dacarbazine, Docetaxel, Doxorubicin HCI, Etoposide, Fluorouracil, Ifosfamide, Mechlorethamine HCI, Methotrexate, Mitomycin, Mitoxantrone, Paclitaxel, Vincristine Sulfate. |
| Low permeation times of less than 60 minutes for: Carmustine (BCNU) (44.7 minutes), ThioTepa (35.7 minutes). | |||
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the potential of the material to produce skin irritation in rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential in guinea pigs | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item | Under the conditions of study, no more than grade 2 cytotoxic reaction | Slight (Grade 1) cytotoxicity reaction observed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each physical and chemical test (e.g., number of gloves tested for dimensions, holes, etc.). The testing was conducted according to established ASTM and ISO standards, which typically specify the required sample sizes for each test.
The data provenance is from Jiangsu Nanfang Medical Co., Ltd in China. The tests were non-clinical, laboratory-based performance tests, not involving human subjects or patient data, so the terms "retrospective" or "prospective" are not applicable in this context.
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)
This is not applicable. The "ground truth" for this device is based on objective, quantifiable physical, chemical, and biological measurements performed according to standardized testing protocols (e.g., ASTM, ISO). There is no "expert" interpretation or "ground truth" establishment in the sense of clinical image analysis or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the testing involves objective laboratory measurements, not subjective evaluations or interpretation requiring 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 device is a disposable medical glove and does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device is based on objective measurements obtained through standardized physical, chemical, and biological testing methods (ASTM and ISO standards). Examples include:
- Precise measurements of dimensions (width, length, thickness).
- Quantifiable tensile strength and elongation.
- Measured breakthrough times for chemotherapy drugs.
- Results from established biocompatibility tests (skin irritation, sensitization, cytotoxicity) with clear pass/fail criteria.
8. The sample size for the training set
This is not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.