(53 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.
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes 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 glove is ambidextrous, i.e., can be worn on right hand or left hand.
The provided document is a 510(k) premarket notification for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue). This is a medical device of Class I and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI/ML algorithm.
Therefore, the requested information about AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets is not applicable to this document.
The document describes the acceptance criteria and device performance as they relate to the physical and biocompatibility characteristics of the examination gloves. Here's a summary based on the provided text:
1. Acceptance Criteria and Reported Device Performance for Powder Free Nitrile Patient Examination Gloves
The acceptance criteria for these medical gloves are primarily based on established ASTM (American Society for Testing and Materials) and ISO standards. The reported device performance is compared against these standards and the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Device Performance (Current Blue) | Status | Compared to Predicate |
|---|---|---|---|---|---|
| Material | ASTM D6319-10 | Nitrile | Nitrile | Same | Same |
| Color | - | Blue | Blue | Same | Same |
| Texture | - | Finger textured | Finger textured | Same | Same |
| Physical Properties | |||||
| Before Aging | ASTM D6319-10 (Tensile Test: ASTM D412-16) | Tensile Strength: ≥ 14MPa; Ultimate Elongation: ≥ 500% | Tensile Strength: 15.3 MPa (Pass); Ultimate Elongation: 500% (Pass) | Pass | Same |
| After Aging | ASTM D6319-10 (Tensile Test: ASTM D412-16) | Tensile Strength: ≥ 14MPa; Ultimate Elongation: ≥ 400% | Tensile Strength: 14.8 MPa (Pass); Ultimate Elongation: 460% (Pass) | Pass | Same |
| Thickness | ASTM D6319-19 (Measurement: ASTM D3767-03) | Finger: 0.07-0.10mm; Palm: 0.06-0.09mm; Cuff: 0.06-0.08mm | Finger: 0.07-0.10mm; Palm: 0.06-0.09mm; Cuff: 0.06-0.08mm (Within ranges) | Pass | Similar |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | 1.5 mg/glove | Pass | Same |
| Biocompatibility | |||||
| Primary Skin Irritation | ISO 10993-10:2010 | Passes (Not a primary skin irritant); PII = 0 | Passes (Not a primary skin irritant); PII = 0 | Pass | Similar |
| Dermal Sensitization | ISO 10993-10:2010 | Passes (Not a contact sensitizer); No allergic reaction observed | Passes (Not a contact sensitizer); No allergic reaction observed | Pass | Similar |
| Cytotoxicity | ISO 10993-5:2009 (MEM Elution) | No cytotoxicity reactivity at specific extract concentrations (e.g., 12.5%, 6.25%, 3.125%) | No cytotoxicity reactivity at 12.5%, 6.25%, 3.125% extract concentrations | Pass | Similar |
| Acute Systemic Toxicity | ISO 10993-11:2017 (E) | Passes (no adverse biological reaction); No mortality observed | Passes (no adverse biological reaction); No mortality observed | Pass | Not Available for Predicate |
| Watertight (Hole Detection) | ASTM D5151-19 | Inspection Level 1, AQL 1.5; Acceptance No: 10 (for a sample size of 315) | 6 pieces found with leaks (within acceptance criteria) | Pass | Same |
| Dimension | ASTM D3767-03 (2020) | Length: Min 240mm; Width (XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: >110mm); Thickness: Finger ≥ 0.05mm, Palm ≥ 0.05mm | Length: Min 240mm (Pass); Width (Ave: 72mm-113mm for sizes, all Pass); Thickness: Finger 0.10mm, Palm 0.06mm (Pass) | Pass | Part of "Similar" Thickness |
2. Sample Sizes Used for Testing and Data Provenance
The sample sizes for testing are defined by the specific ASTM standards followed.
- Physical Properties (Tensile Strength, Elongation): Not explicitly stated, but typically these tests involve a specified number of specimens per batch or test run according to ASTM D412.
- Watertight (Hole Detection): Sample size of 315 pieces for a batch sampling of 150,001 to 500,000 gloves, based on Inspection Level GI and AQL 1.5. This is a prospective test conducted on manufactured gloves.
- Powder Free (Residual Powder): Sample size of 5 pieces.
- Biocompatibility Tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity): These tests are typically conducted on animal models (e.g., mice, rabbits) and cell cultures. The counts of animals (e.g., number of test group animals vs. control group animals) are not explicitly stated in this summary, but the results (e.g., "no mortality," "no erythema") indicate biological testing. This data would be prospective from laboratory testing.
- Data Provenance: The manufacturing company is Meditech Gloves Sdn Bhd, Malaysia. The tests described are laboratory and quality control tests conducted as part of the manufacturing and regulatory submission process.
3. Number of Experts and Qualifications for Ground Truth
This type of medical device submission (examination gloves) does not involve human expert interpretation of images or complex diagnostic data like an AI/ML device would. Therefore, there are no "experts establishing ground truth" in the diagnostic sense. The "ground truth" for the performance of these gloves is defined by the objective, quantifiable results of the standardized physical and biocompatibility tests (e.g., direct measurements of tensile strength, elongation, amount of powder, number of leaks, observed biological reactions in laboratory tests).
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The tests are objective and quantitative.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML diagnostic device that interacts with human readers or interprets medical cases.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical examination glove, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for this device is based on objective, quantitative measurements and laboratory test results against established international standards (ASTM, ISO) for material properties, physical dimensions, leak detection, and biocompatibility.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.
In summary, the provided document is a regulatory submission for a physical medical device (examination gloves) where "acceptance criteria" relate to meeting specific physical and biological performance standards, not to the performance of an AI/ML algorithm.
§ 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.