(222 days)
A 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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
This is a 510(k) summary for a medical device (Powder Free Nitrile Examination Gloves, Blue, Chemotest), not an AI/ML device. Therefore, the sections regarding AI/ML device assessment criteria (such as sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Here's the relevant information extrapolated from the document regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Inspection level G-I, AQL 2.5 | Pass |
| Dimension | ASTM D6319-19 | Length, min. (mm): XSmall 220, Small 220, Medium 230, Large 230, XLarge 230 | Pass (Meets requirements for all sizes) |
| Thickness, min. (mm): 0.05 (palm, finger) | Pass (Meets 0.05mm min) | ||
| Width, ± 10 (mm): XSmall 70, Small 80, Medium 95, Large 110, XLarge 120 | Pass (Meets requirements for all sizes) | ||
| Physical Properties (Before Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. | Pass (Meets 14MPa min.) |
| Ultimate Elongation: 500 % min. | Pass (Meets 500% min.) | ||
| Physical Properties (After Accelerated Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. | Pass (Meets 14MPa min.) |
| Ultimate Elongation: 400 % min. | Pass (Meets 400% min.) | ||
| Residual Powder Content | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass (Meets 2mg/glove max.) |
| Biocompatibility - Primary Skin Irritation Test | ISO 10993-10 | No Irritation | No irritant response |
| Biocompatibility - Skin Sensitization Test | ISO 10993-10 | No Irritation | No skin sensitization effect |
| Biocompatibility - In Vitro Cytotoxicity Test | ISO 10993-5:2009 | (No specific numerical criteria, evaluated for reactivity) | Moderate cytotoxicity reactivity at 6.0 cm²/mL; No cytotoxicity reactivity at 3.0 cm²/mL |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11 | (No specific numerical criteria, evaluated for adverse biological reactions) | No adverse biological reaction |
| Chemotherapy Drugs Permeation Time | ASTM D6978-05 | (Breakthrough detection time in minutes per drug) | Carmustine (BCNU): 22.6 min (WARNING: Not recommended for use) |
| Cisplatin: >240 min | |||
| Cyclophosphamide (Cytoxan): >240 min | |||
| Dacarbazine: >240 min | |||
| Doxorubicin HCL: >240 min | |||
| Etoposide: >240 min | |||
| Fluorouracil: >240 min | |||
| Ifosfamide: >240 min | |||
| Mitoxantrone: >240 min | |||
| Paclitaxel: >240 min | |||
| Thio Tepa: 43.9 min (WARNING: Not recommended for use) | |||
| Vincristine Sulfate: >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 explicitly state the sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, holes, or physical properties). However, it implies that the testing was conducted according to the specified ASTM and ISO standards, which would dictate appropriate sample sizes for each test method.
The data provenance is not explicitly stated in terms of country of origin of the testing data itself, but the applicant is Careglove Global SDN BHD from Malaysia. The studies are non-clinical, laboratory-based tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is for a physical medical device (examination gloves) and not an AI/ML diagnostic or predictive device requiring ground truth from human experts. The "truth" is established by physical measurement against standard specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies primarily to AI/ML clinical studies where human readers might adjudicate discrepancies or define ground truth. For physical device testing, results are measured and compared against established standards.
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, as 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, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference values for device performance are defined by recognized international and national standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Standard Test Method for Residue on Medical Gloves)
- ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
The device's performance is compared directly to the specifications outlined in these standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and therefore does not have a "training set" with established ground truth.
§ 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.