(62 days)
The Nitrile Glove Powder Free Black is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is black. The proposed device is non-sterile.
This document is a 510(k) summary for a Nitrile Glove Powder Free Black, classifying it as a Class I medical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K171422).
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria & Reported Device Performance:
The document presents a "Technological Characteristic Comparison Table" (Table 1), "Device Dimensions Comparison" (Table 2), "Performance Comparison" (Table 3), and "Safety Comparison" (Table 4) where the proposed device's performance is compared against the predicate device and relevant standards. This serves as the primary method to demonstrate that the proposed device meets the acceptance criteria (substantial equivalence to the predicate and compliance with recognized standards).
| Acceptance Criteria Type | Acceptance Criteria | Proposed Device Performance (K182528) | Predicate Device Performance (K171422) | Comparison/Outcome |
|---|---|---|---|---|
| General Characteristics | ||||
| Product Code | LZA | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Intended Use | To prevent contamination between patient and examiner. | Same as predicate (quoted directly) | Same as proposed (quoted directly) | Same |
| Powdered Status | Powdered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Nitrile Glove Powder Free Black, Non-Sterile | Disposable Powder Free Nitrile Examination Glove, Non-Sterile | Same (description-wise) |
| Dimensions | According to the predicate device's specifications | |||
| Length, mm (all sizes) | 230 min | 230 min | 230 min | Same |
| Width, mm (XS, S, M, L, XL) | 75, 85, 95, 105, 115 ±5 | 75, 85, 95, 105, 115 ±5 | 75, 85, 95, 105, 115 ±5 | Same |
| Thickness, mm (Finger, Palm) | 0.05 min | 0.05 min | 0.05 min | Same |
| Physical Properties (Before Aging) | ||||
| Tensile Strength | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 500% min | 500% min | 500% min | Same |
| Physical Properties (After Aging) | ||||
| Tensile Strength | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 400% min | 400% min | 400% min | Same |
| Compliance with Standard | Comply with ASTM D6319 | Comply with ASTM D6319 | Comply with ASTM D6319 | Same |
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151, AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151, AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151, AQL=2.5 | Same |
| Powder Content | Meet the requirements of ASTM D6124 | 0.48 mg per glove | Meet the requirements of ASTM D6124 | Similar (Specific value versus general compliance statement for predicate; assumed to meet the same standard) |
| Material Safety | ||||
| Material | Nitrile | Nitrile | Nitrile | Same |
| Biocompatibility: Irritation (ISO 10993-10:2010) | Not an irritant | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same |
| Biocompatibility: Sensitization (ISO 10993-10:2010) | Not a sensitizer | Under conditions of the study, not a sensitizer. | Under conditions of the study, not a sensitizer. | Same |
| Biocompatibility: Cytotoxicity (ISO 10993-5:2009) | No potential toxicity to L-929 cells | Under conditions of the study, did not show potential toxicity to L-929 cells. | N/A (indicated by '/') | Similar (predicate doesn't explicitly state cytotoxicity but proposed device meets standard) |
2. Sample Sizes and Data Provenance (for test set, if applicable):
The document states, "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, it does not specify the sample sizes used for these non-clinical tests (e.g., how many gloves were tested for Freedom from Holes, Tensile Strength, etc.).
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data, other than the submitting company being located in China. Given the nature of these tests (bench testing for physical and chemical properties), they would typically be prospective tests performed on samples of the manufactured device.
3. Number of Experts and Qualifications (for ground truth of test set):
This information is not applicable to this submission type. Ground truth in this context typically refers to clinical diagnosis or pathology readouts. For a Class I medical device like a glove, the "ground truth" is adherence to physical/chemical standards and biocompatibility tests, not expert clinical interpretation. The "experts" would be the personnel in the testing laboratories conducting the ASTM and ISO standard tests. Their qualifications are inherent in their ability to perform these accredited tests.
4. Adjudication Method (for test set):
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic accuracy, where multiple human readers interpret data, and a consensus mechanism is employed to establish ground truth or resolve discrepancies. For physical and biocompatibility testing of a medical glove, objective laboratory test results are obtained, and no such adjudication is necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done and is not relevant for this type of device. MRMC studies are typically performed for diagnostic imaging devices to assess the impact of AI on reader performance.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not done and is not applicable. This is a physical product (a glove), not an algorithm or AI-powered device.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance is established through:
- Compliance with recognized international and national standards: ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-06, and ASTM D6319-10. These standards define the acceptable performance characteristics for medical gloves.
- Comparison to a legally marketed predicate device (K171422): Demonstrating that the proposed device's characteristics (dimensions, physical properties, material, biocompatibility) are substantially equivalent to a device already cleared by the FDA.
8. Sample Size for the Training Set:
This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this 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.