(288 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand 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, Simulated Gastric Acid, and Fentanyl Citrate.
The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand.
The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).
This document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves. The "device" in question is medical examination gloves, not an AI/ML powered medical device, therefore many of the requested criteria (e.g., number of experts, MRMC studies, training/test set ground truth establishment) are not applicable.
However, I can extract information related to acceptance criteria and performance as presented in the document for the glove device.
Here's the relevant information based on the provided document:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance | Meets Criteria? | Reference Standard |
|---|---|---|---|---|
| Biocompatibility | ||||
| Irritation Testing | Pass | Not a primary skin irritant | Yes | ISO 10993-10 |
| Sensitization Testing | Pass | Not a primary skin sensitizer | Yes | ISO 10993-10 |
| In Vitro Cytotoxicity Testing | Pass | Exhibit cytotoxicity reactivity | No | ISO 10993-5 |
| Systemic Toxicity | Pass | Not toxic | Yes | ISO 10993-11 |
| Physical Dimensions (ASTM D6319-19) | ||||
| Length (XS, S) | 220 mm min | 240 - 245 mm | Yes | ASTM D6319-19 |
| Length (M, L, XL, XXL) | 230 mm min | 240 - 245 mm (M), 240-243 mm (L, XL), 240 - 242 mm (XXL) | Yes | ASTM D6319-19 |
| Width (X-Small) | 70 ± 10 mm | 77-79 mm | Yes | ASTM D6319-19 |
| Width (Small) | 80 ± 10 mm | 84-86 mm | Yes | ASTM D6319-19 |
| Width (Medium) | 95 ± 10 mm | 95-97 mm | Yes | ASTM D6319-19 |
| Width (Large) | 110 ± 10 mm | 104-106 mm | Yes | ASTM D6319-19 |
| Width (Extra-Large) | 120 ± 10 mm | 111-115 mm | Yes | ASTM D6319-19 |
| Width (XX-Large) | 130 ± 10 mm | 120-123 mm | Yes | ASTM D6319-19 |
| Palm Thickness | 0.05 mm min | 0.12 mm | Yes | ASTM D6319-19 |
| Finger Thickness (XS, S) | 0.08 mm min | 0.13 mm | Yes | ASTM D6319-19 |
| Finger Thickness (M, L, XL, XXL) | 0.05 mm min | 0.13 mm | Yes | ASTM D6319-19 |
| Physical Properties (ASTM D6319-19) | ||||
| Tensile Strength (Before Aging) | 14 MPa min | 17.55 – 20.90 MPa | Yes | ASTM D6319-19 |
| Tensile Strength (After Aging) | 14 MPa min | 15.00 – 19.95 MPa | Yes | ASTM D6319-19 |
| Ultimate Elongation (Before Aging) | 500% min | 750 – 830% | Yes | ASTM D6319-19 |
| Ultimate Elongation (After Aging) | 400% min | 625 – 770% | Yes | ASTM D6319-19 |
| Freedom from Holes (ASTM D5151-06) | ||||
| AQL | AQL 2.5 | Passed Standard Acceptance (XS/XXL – 0/160; S/M/XL – 1/250; L – 2/250) | Yes | ASTM D5151-06 |
| Powder Content (ASTM D6124-06) | ||||
| Residual Powder Content | 240 min desired) | 58.3 min | No (Warning issued) | ASTM D6978-05 |
| ThioTepa | N/A (>240 min desired) | 119 min | No (Warning issued) | ASTM D6978-05 |
| Other Chemotherapy Drugs (13 tested) | > 240 min | > 240 min | Yes | ASTM D6978-05 |
| Simulated Gastric Acid Fluid | > 240 min | > 240 min | Yes | ASTM D6978-05 |
| Fentanyl Citrate Injection | > 240 min | > 240 min | Yes | ASTM D6978-05 |
2. Sample size used for the test set and the data provenance:
The document mentions sample sizes indirectly through "Inspection Level G-1" and "AQL 2.5" which are statistical sampling plans. For instance, for freedom from holes, it states: "XS/XXL – 0/160; S/M/XL – 1/250; L – 2/250", which implies a sample size of 160 or 250 units depending on the glove size, with an allowable number of non-conforming units (holes) of 0, 1, or 2.
The data provenance is not explicitly stated as "country of origin of the data" or "retrospective/prospective." However, the submitter's address is "PT. MAJA AGUNG LATEXINDO Jl. Utama No. 98, Pujimulyo, Sunggal 20352 Deli Serdang North Sumatera - Indonesia," suggesting the testing was conducted in Indonesia or by a lab associated with the manufacturer. The testing methods refer to ASTM standards, which are internationally recognized. This is pre-market testing, so it's inherently prospective data for the regulatory submission.
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. This device is a physical product (medical gloves) and not an AI/ML medical device. "Ground truth" in this context refers to measurements against established physical and chemical standards, not expert interpretations of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an image-based or clinical data-based study requiring adjudication. The results are objective measurements from laboratory 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. No AI/ML component in this medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No algorithm component in this medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on established, objective, and quantifiable performance criteria defined by recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for medical gloves. This includes:
- Physical dimensions
- Physical properties (tensile strength, elongation)
- Freedom from pinholes (measured by water leak test)
- Residual powder content
- Permeation resistance to specific chemicals (measured as breakthrough time)
- Biocompatibility (in vitro/in vivo tests for irritation, sensitization, cytotoxicity, systemic toxicity).
8. The sample size for the training set:
Not applicable. No training set is used as this is not an AI/ML device. The testing described pertains to product validation and verification against established performance standards.
9. How the ground truth for the training set was established:
Not applicable. No training set is used. The "ground truth" for the performance metrics is established by the test methods outlined in the aforementioned ASTM and ISO standards. These standards prescribe the procedures and criteria for evaluating the glove's performance.
§ 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.