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510(k) Data Aggregation
(112 days)
The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The provided text is a 510(k) Premarket Notification from the FDA for "Disposable Nitrile Gloves." This document primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving that it meets acceptance criteria for an AI/algorithm-based diagnostic device through a study with human readers.
Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for AI test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth establishment for training sets, and the number and qualifications of experts for ground truth, is not applicable to this document.
The document describes performance testing for a physical medical device (gloves) against established standards for physical properties and biocompatibility.
Here's an analysis based on the information available in the document, framed to address the prompt's structure where possible, but highlighting the inapplicability of AI-specific criteria.
Analysis of Acceptance Criteria and Device Performance (for Disposable Nitrile Gloves)
The document, K211781, describes the submission for Disposable Nitrile Gloves. The "acceptance criteria" in this context refer to the performance specifications and safety standards for the physical product, not for an AI/algorithm. The study presented is a series of non-clinical bench tests and biocompatibility assessments demonstrating the gloves meet these standards and are substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are derived from recognized standards (ASTM and ISO). The reported device performance shows the proposed device meets or exceeds these criteria.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Tests | |||
| ISO 10993-10:2010 (Irritation & Skin Sensitization) | Assess potential contact hazards (skin/mucosal irritation, eye irritation, skin sensitization). | Skin Sensitization: Grades less than 1. Skin Irritation: Primary Irritation Index 0-0.4 (Negligible). | All grades are 0. All animals survived with no abnormal signs. Primary irritation index is 0 (negligible response). |
| ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess in vitro cytotoxicity. | Viability reduced to <70% of blank indicates cytotoxic potential. | Viab.% of 100% test article extract is 13.7%. Indicates potential toxicity to L-929 in MTT method. (Note: This is a deviation from the "positive" acceptance criteria, but later mitigated by systemic toxicity test). |
| ISO 10993-11:2017 (Systemic Toxicity) | Evaluate potential for medical device materials to cause adverse systemic reactions. | Within 72h, no greater toxicosis response in testing group than control group. | No evidence of systemic toxicity from the extract. (This mitigates the cytotoxicity finding, suggesting it's not systemically toxic). |
| Physical Properties Tests | |||
| ASTM D6124-06 (Reapproved 2017), Residual Powder on Medical Gloves | Determine amount of residual powder. | Powder residue limit of 2.0 mg. | 0.06 mg/glove. (Meets criterion). |
| ASTM D5151-19, Detection of Holes in Medical Gloves | Cover detection of holes in medical gloves. | Samples: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤ 7 gloves for water leakage. | No glove water leakage found. (Meets criterion). |
| ASTM D6319-19, Nitrile Examination Gloves for Medical Application | Covers general requirements (sterility, freedom from holes, dimensions, thickness, physical properties). | Sterility: No need (for this non-sterile device). Freedom from holes: AQL 2.5. Dimensions: (e.g., S: width 80±10mm, L ≥220mm; M: width 95±10mm, L ≥230mm; L: width 110±10mm, L ≥230mm; XL: width 120±10mm, L ≥230mm). Thickness: Finger ≥0.05 mm, Palm ≥0.05 mm. Physical Properties: (Before Aging) Tensile strength ≥14MPa, Ultimate Elongation ≥500%. (After Aging) Tensile strength ≥14MPa, Ultimate Elongation ≥400%. | N.A. for sterility. Freedom from holes: Met (as per D5151). Dimensions: S: width 84-88 mm, L 251-261 mm; M: width 91-95 mm, L 252-256 mm; L: width 103-106 mm, L 250-256 mm; XL: width 118-121mm, L 253-261 mm. (All meet D6319-19 requirements, though different from predicate detailed in Table 2). Thickness: Finger 0.14-0.15 mm, Palm 0.08-0.09 mm. (All meet D6319-19 requirements). Physical Properties: (Before Aging) Tensile strength 14.67-26.48 MPa, Ultimate Elongation 585.48% - 846.81%. (After Aging) Tensile strength 14.40-22.23 MPa, Ultimate Elongation 527.73% - 775.00%. (All meet D6319-19 requirements). |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For Freedom from Holes (ASTM D5151-19): 125 gloves.
- For other physical tests (Dimensions, Thickness, Physical Properties, Powder Content): Not explicitly stated as a "test set" sample size but implied by compliance with ASTM D6319-19, which dictates sampling plans.
- For Biocompatibility Tests (ISO 10993): Animal study sample sizes (for irritation, sensitization, systemic toxicity) are not explicitly stated, but are standard for these in vivo tests. Cell cultures are used for cytotoxicity.
- Data Provenance: The testing was conducted by or on behalf of "Jiangsu Jinke Protective Equipment Co., Ltd" in China. The data would be considered prospective, as it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device. "Ground truth" in this context refers to the measured physical and biological properties of the gloves as determined by validated test methods and laboratory analysis, not by human expert interpretation of images or other data. No human experts were used to establish "ground truth" for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is for a physical medical device. Not an AI diagnostic study.
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. No AI component; therefore, no MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No AI component; therefore, no standalone AI performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For physical properties, the ground truth is established by objective measurements using standardized laboratory equipment and methods (e.g., tensile testers for strength, calipers for dimensions, water for hole detection, chemical analysis for powder content).
- For biocompatibility, the ground truth is established by biological responses observed in validated in vitro (cytotoxicity) or in vivo (irritation, sensitization, systemic toxicity) animal models according to ISO standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; there is no training set in the context of AI.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
Conclusion from the Document:
The document successfully demonstrates that the Disposable Nitrile Gloves meet the performance specifications outlined in relevant ASTM and ISO standards for physical properties and biocompatibility, particularly when compared to the predicate device. The one noted 'potential cytotoxicity' was mitigated by a successful systemic toxicity test. The regulatory submission hinges on substantial equivalence rather than AI performance criteria.
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