(52 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drugs Permeation
The following chemicals have been tested with these gloves.
Test Chemotherapy Drugs Concentration Breakthrough Detection Time in minutes *Carmustine 3.3mg/ml 24.8 Cisplatin 1 mg/ml >240 Cyclophosphamide 20 mg/ml >240 Dacarbazine 10 mg/ml >240 Doxorubicin, HCl 2 mg/ml >240 Etoposide 20 mg/ml >240 Fluorouracil 50 mg/ml >240 Methotrexate 25 mg/ml >240 Mitomycin C 0.5 mg/ml >240 Oxaliplatin 5 mg/ml >240 Paclitaxel 6 mg/ml >240 *Thiotepa 10 mg/ml 38.4 Vincristine 1 mg/ml >240
Warning- Not for use with Carmustine and Thiotepa.
Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250.
Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs are Class I patient examination gloves bear the product code Nitrile – LZA (21CFR880.6250).
The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are blue in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in four sizes (S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
The provided document is a 510(k) Premarket Notification for "Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs". This document outlines the acceptance criteria and performance data for a medical device that is a physical commodity, not an AI/ML powered device. As such, information regarding AI/ML specific criteria like human-in-the-loop performance, effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, or training set details are not applicable and not present in the document.
The acceptance criteria and reported device performance are based on recognized ASTM and ISO standards for medical gloves.
Here's the information extracted from the provided text, structured according to your request where applicable for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
| Characteristics and Parameters | Standard | Acceptance Criteria | Reported Device Performance and Results |
|---|---|---|---|
| Chemotherapy Drugs Permeation Test (ASTM D6978-05 (2019)) | ASTM D6978-05 | Minimum Breakthrough Detection Time (min) | |
| Carmustine | - | 24.8 | 24.8 min |
| Cisplatin | - | >240 | >240 min |
| Cyclophosphamide | - | >240 | >240 min |
| Dacarbazine | - | >240 | >240 min |
| Doxorubicin, HCl | - | >240 | >240 min |
| Etoposide | - | >240 | >240 min |
| Fluorouracil | - | >240 | >240 min |
| Methotrexate | - | >240 | >240 min |
| Mitomycin C | - | >240 | >240 min |
| Oxaliplatin | - | >240 | >240 min |
| Paclitaxel | - | >240 | >240 min |
| Thiotepa | - | 38.4 | 38.4 min |
| Vincristine | - | >240 | >240 min |
| Residual Powder Content | ASTM D6124-06 (Reapproved 2017) | Less than 2mg / glove | Size S 0.32mg /glove, Size M 0.28mg /glove, Size L 0.32mg /glove, Size XL 0.30mg /glove |
| Freedom from Holes | ASTM D5151-19 | Inspection level, G-I AQL 2.5 (In accordance with ASTM D6319-19) | Passed G-I, AQL 1.5 |
| Physical Dimensions - Length | ASTM D6319-19 | Size S 220mm, min; Size M 230mm, min; Size L 230mm, min; Size XL 230mm, min | Size S 250 - 255mm, Size M 250 - 255mm, Size L 245 - 252mm, Size XL 245 - 252mm |
| Physical Dimensions - Width | ASTM D6319-19 | Size S 80 ± 10mm; Size M 95 ± 10mm; Size L 110 ± 10mm; Size XL 120 ± 10mm | Size S 83 - 85mm, Size M 93 - 96mm, Size L 105 - 109mm, Size XL 116 - 118mm |
| Physical Dimensions - Thickness (Cuff) | ASTM D6319-19 | Measured in single wall at cuff edge area Cuff 0.05mm, min | Size S 0.05 - 0.06mm, Size M 0.05 - 0.06mm, Size L 0.05 - 0.06mm, Size XL 0.05 - 0.06mm |
| Physical Dimensions - Thickness (Palm) | ASTM D6319-19 | Measured in single wall at approximate center of palm area Palm 0.05mm, min | Size S 0.06 - 0.07mm, Size M 0.06 - 0.06mm, Size L 0.06 - 0.07mm, Size XL 0.06 - 0.07mm |
| Physical Dimensions - Thickness (Finger) | ASTM D6319-19 | Measured in single wall at 13±3mm from the tip of middle finger Finger 0.05mm, min | Size S 0.08 - 0.09mm, Size M 0.09 - 0.10mm, Size L 0.10 - 0.11mm, Size XL 0.10 - 0.11mm |
| Tensile Strength (Before aging) | ASTM D6319-19 | 14MPa, min for all sizes | Size S 21.94 MPa, average; Size M 22.08 MPa, average; Size L 21.76 MPa, average; Size XL 22.05 MPa, average |
| Tensile Strength (After accelerated aging) | ASTM D6319-19 | 14MPa, min for all sizes | Size S 29.53 MPa, average; Size M 29.12 MPa, average; Size L 24.90 MPa, average; Size XL 29.63 MPa, average |
| Ultimate Elongation (Before aging) | ASTM D6319-19 | 500%, min for all sizes | Size S 537%, average; Size M 550%, average; Size L 526%, average; Size XL 536%, average |
| Ultimate Elongation (After accelerated aging) | ASTM D6319-19 | 400%, min for all sizes | Size S 452%, average; Size M 450%, average; Size L 436%, average; Size XL 458%, average |
| Animal Irritation Test (ISO 10993-10) | ISO 10993-10 | Under the condition of study not an irritant. | No observable irreversible alteration on the skin; Primary Irritation Index (PII) was "0"; not corrosive; Primary Irritation Response Category is "negligible". |
| Dermal Sensitization Assay Test (ISO 10993-10) | ISO 10993-10 | Under the condition of the study not a sensitizer. | No sensitization induced by the application of the test material on albino guinea pigs. |
| Acute Systemic Toxicity (ISO 10993-11) | ISO 10993-11 | Not induce systemic toxicity | The single dose acute systemic toxicity of extracts from test material using both normal saline and sesame oil, shown non-toxic effects. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for each characteristic) or the detailed data provenance beyond adherence to international standards like ASTM and ISO. Given the nature of product testing for medical gloves, it is implied that appropriate sample sizes were used as prescribed by the respective ASTM and ISO standards. The tests are non-clinical (bench tests and biocompatibility tests). There is no explicit mention of data provenance in terms of country of origin or retrospective/prospective data collection for these 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 "ground truth" for physical properties and chemical permeation of medical gloves is established by the specified ASTM and ISO standards and their defined methodologies, not by expert consensus on specific samples in the same way an AI model's output would be adjudicated. The tests are objective measurements against defined criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements according to established standards. There is no human adjudication process described for these types of tests.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is defined by the technical specifications and methodologies outlined in the referenced ASTM standards (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 (2019) for chemotherapy drug permeation, ASTM D6124-06 for residual powder, ASTM D5151-19 for freedom from holes) and ISO standards (e.g., ISO 10993-10 and ISO 10993-11 for biocompatibility). These standards provide objective measurement criteria and test protocols.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.