(79 days)
The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
The provided text describes a 510(k) summary for a medical device called "Blue Nitrile Exam Glove, Powder Free" (K210057). This document focuses on demonstrating substantial equivalence to a predicate device (K171422) rather than conducting a standalone study to prove acceptance criteria for a novel device. Therefore, many of the requested categories related to a detailed study on performance, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, and ground truth for training sets, are not applicable in this context.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM and ISO standards for examination gloves. The "reported device performance" is essentially the statement that the device complies with these standards and the listed physical property values.
| Item | Acceptance Criteria (Standard / Predicate Value) | Subject Device Performance (K210057) | Remark |
|---|---|---|---|
| General | |||
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Same as Predicate | Same as Predicate | Same |
| Powdered/Powder-free | Powder-free | Powder-free | Said to be "Powdered free" in table for subject device |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Dimensions | Compliance with ASTM D6319-19. Differences do not raise new safety/performance questions. | ||
| Length, mm (all sizes) | Predicate: 230 min | Subject: 230 (S, M, L, XL) | Subject device has a tolerance of $\pm 10$ mm, while the predicate has "min" |
| Width, mm | Predicate: XS(75), S(85), M(95), L(105), XL(115) $\pm 5$ | Subject: S(80), M(95), L(110), XL(120) $\pm 10$ | Different exact values and sizes, but both claim to meet ASTM D6319-19 |
| Thickness, mm: Finger | Predicate: 0.05 min | Subject: 0.08 $\pm 0.03$ | Different values, but both claim to meet ASTM D6319-19 |
| Thickness, mm: Palm | Predicate: 0.05 min | Subject: 0.08 $\pm 0.03$ | Different values, but both claim to meet ASTM D6319-19 |
| Physical Properties (Before Aging) | ASTM D6319-19 / Predicate: 14MPa, min | Subject: 14MPa, min | Same |
| Tensile Strength | ASTM D6319-19 / Predicate: 500% min | Subject: 500% min | Same |
| Ultimate Elongation | |||
| Physical Properties (After Aging) | ASTM D6319-19 / Predicate: 14MPa, min | Subject: 14MPa, min | Same |
| Tensile Strength | ASTM D6319-19 / Predicate: 400% min | Subject: 400% min | Same |
| Ultimate Elongation | |||
| Freedom from Holes | ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same |
| Powder Content | ASTM D6124 / Predicate requirements for ASTM D6124 | 0.03 mg per glove (meets ASTM D6124) | Same |
| Biocompatibility - Irritation | ISO 10993-10:2010 / Predicate: not an irritant | Not an irritant (Comply with ISO10993-10) | Same |
| Biocompatibility - Sensitization | ISO 10993-10:2010 / Predicate: not a sensitizer | Not a sensitizer (Comply with ISO10993-10) | Same |
| Biocompatibility - Cytotoxicity | ISO 10993-5:2009 / Predicate: not cytotoxic | Not cytotoxic | Similar |
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 specify a "test set" in the context of a dataset for an AI/algorithm, as the device is a physical product (medical glove). The "tests" mentioned are non-clinical standard conformance tests (e.g., physical property testing, biocompatibility).
- Sample Size: The sample sizes for each specific standard test (e.g., number of gloves for tensile strength, number of gloves for hole detection) are not explicitly stated in this summary but would be defined by the respective ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151).
- Data Provenance: Not specified, but the testing was conducted to verify compliance with international standards (ISO, ASTM). The manufacturer is in China (Real Star Medical Technology Co., Ltd. in Dongying, China).
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)
This is not applicable as the device is a physical product (medical glove) and the evaluation involves standard physical and chemical testing, not clinical diagnosis by experts or expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation relies on meeting objective criteria defined by recognized standards (ASTM, ISO), not on subjective interpretation requiring adjudication.
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. This is a medical glove, not an AI diagnostic or assistance device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims is defined by the objective measurement criteria and thresholds established within the referenced international standards (ASTM D6319-19, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, ISO 10993-5:2009). For example, "Tensile Strength (Before Aging) $\ge$ 14MPa" is a ground truth established by the ASTM D6319-19 standard.
8. The sample size for the training set
Not applicable. There is no training set for a physical medical device. The device's manufacturing processes are subject to quality system regulations, but this is distinct from "training data" for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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.