(86 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface 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 or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided document describes the non-clinical performance testing for a medical device: "Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile." This submission is a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Before Aging Tensile Strength | ASTM D412, ASTM D6319 | Min 14.0 MPa | XS: 28.9 MPa, S: 27.8 MPa, M: 28.7 MPa, L: 28.3 MPa, XL: 28.0 MPa | Pass |
| Before Aging Ultimate Elongation | ASTM D412, ASTM D6319 | Min 500% | XS: 540%, S: 530%, M: 560%, L: 540%, XL: 540% | Pass |
| After Aging Tensile Strength | ASTM D412, ASTM D6319 | Min 14.0 MPa | XS: 31.7 MPa, S: 32.1 MPa, M: 32.4 MPa, L: 31.9 MPa, XL: 31.5 MPa | Pass |
| After Aging Ultimate Elongation | ASTM D412, ASTM D6319 | Min 400% | XS: 480%, S: 470%, M: 490%, L: 480%, XL: 490% | Pass |
| Dimensions (ASTM D3767) | ||||
| Length (all sizes) | Min 240 mm | XS: 244 mm, S: 245 mm, M: 244 mm, L: 243 mm, XL: 242 mm | Pass | |
| Width | ||||
| XS | $70 \pm 10$ mm | 74.0 mm | Pass | |
| S | $80 \pm 10$ mm | 85.0 mm | Pass | |
| M | $95 \pm 10$ mm | 95.0 mm | Pass | |
| L | $110 \pm 10$ mm | 106 mm | Pass | |
| XL | $120 \pm 10$ mm | 117 mm | Pass | |
| Thickness - Finger (all sizes) | Min 0.05 mm | 0.10 mm (for XS, S, M, L, XL) | Pass | |
| Thickness - Palm (all sizes) | Min 0.05 mm | 0.06 mm (for XS, S, M, L, XL) | Pass | |
| Watertight | ASTM D5151, ISO 2859 | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | The test found 1 leak for XS, 3 for S, 2 for M, 3 for L, and 1 for XL. All are within the acceptance criteria (total max 10 leaks for the batch size). | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | XS: 0.26 mg/glove, S: 0.32 mg/glove, M: 0.28 mg/glove, L: 0.34 mg/glove, XL: 0.38 mg/glove | Pass |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10:2010, CPSC 16 CFR 1500 | Passes | The test material did not cause an irritant response. Primary Irritant Response Category deemed 'Negligible'. | Pass |
| Dermal Sensitization | ISO 10993-10:2010, CPSC 16 CFR 1500 | Passes | The test material did not produce a skin sensitization effect in the guinea pigs. | Pass |
| Cytotoxicity - MEM Elution | ISO 10993-5:2009 | Passes | The Systemic Toxicity study was conducted as the accepted alternative to the cytotoxic test. | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Not explicitly stated as "Passes" in a single column but the predicate did not test this; results show device passed. | The test item did not induce any systemic toxicity in Swiss albino mice. | Pass |
2. Sample Sizes and Data Provenance:
- Test Set (Current Device):
- Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but tests were performed for different glove sizes (XS, S, M, L, XL). ASTM D412 and D6319 typically specify sample sizes.
- Dimensions (Length, Width, Thickness): Not explicitly stated, but performed for all glove sizes (XS, S, M, L, XL). ASTM D3767 specifies measurement practices.
- Watertight: 315 pieces (for a batch size of 150,001 to 500,000).
- Residual Powder: 5 pieces.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Not explicitly stated for each test, but typically involves animal subjects (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity).
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would be prospective for this specific device.
3. Number of Experts and Qualifications for Ground Truth for the Test Set:
This document describes non-clinical performance testing of a physical medical device (gloves). The ground truth for this type of device is established through standardized laboratory tests according to recognized ASTM and ISO standards, not via expert consensus or clinical evaluation in the same way as, for example, an AI diagnostic tool. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context doesn't directly apply as it would for a clinical study or AI performance evaluation. The "experts" are implicitly the technicians and scientists performing the tests according to the defined standards.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements and evaluations against specified pass/fail criteria from recognized standards (ASTM, ISO). There is no "adjudication" between multiple human readers or interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices or imaging tools where human readers are involved in interpreting results. This submission is for a physical medical device (gloves) and focuses on non-clinical performance characteristics.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used:
The ground truth used is based on:
- Standardized Test Methods: Adherence to established and recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards.
- Quantitative Measurements: Direct measurements of physical properties (tensile strength, elongation, dimensions, powder content).
- Qualitative Assessments: Outcomes of biocompatibility tests (irritation, sensitization, toxicity) as defined by ISO standards on animal models.
- Statistical Sampling: For watertightness, an Acceptance Quality Limit (AQL) statistical sampling plan (ISO 2859) is used.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of medical device which undergoes standardized physical and chemical testing. This is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set. The device's performance is evaluated directly against pre-established, widely accepted industry standards and regulatory requirements for medical examination gloves.
§ 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.