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510(k) Data Aggregation
(101 days)
The Nitrile Examination Golves Powder Free is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided text describes the acceptance criteria and a study for the "Nitrile Examination Gloves Powder Free" (K212921). This is a physical medical device (gloves), not an AI/ML algorithm or software as a medical device (SaMD). Therefore, many of the requested fields related to AI/ML studies (like effect size of human readers with AI assistance, number of experts for ground truth, adjudication methods, details of training set) are not applicable to this submission.
Here is the information derived from the provided document, with "N/A" for sections not applicable to this physical device:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | S: ≥220mm; M/L/XL: ≥230mm | Length: > 230mm (Pass) |
| ASTM D6319 | Physical Dimensions Test (Width) | S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm | S: 86-87mm (Pass); M: 97-98mm (Pass); L: 107-108mm (Pass); XL: 115-116mm (Pass) |
| ASTM D6319 | Physical Dimensions Test (Thickness) | Finger: ≥0.05mm; Palm: ≥0.05mm | S: Finger: 0.10-0.11mm (Pass), Palm: 0.06-0.07mm (Pass); M: Finger: 0.11-0.12mm (Pass), Palm: 0.06-0.07mm (Pass); L: Finger: 0.11-0.12mm (Pass), Palm: 0.06-0.07mm (Pass); XL: Finger: 0.11-0.12mm (Pass), Palm: 0.07mm (Pass) |
| ASTM D5151 | Watertightness Test for Detection of Holes | AQL 2.5 | 0/200 (Pass) |
| ASTM D6124 | Powder Content | < 2.0mg | 0.04mg (Pass) |
| ASTM D412 | Physical Properties (Before Aging - Tensile Strength) | ≥14MPa | 23.3-35.2 (Pass) |
| ASTM D412 | Physical Properties (Before Aging - Ultimate Elongation) | ≥500% | 496-529 (Pass) |
| ASTM D412 | Physical Properties (After Aging - Tensile Strength) | ≥14MPa | 20.0-44.5 (Pass) |
| ASTM D412 | Physical Properties (After Aging - Ultimate Elongation) | ≥400% | 450-500 (Pass) |
| ISO 10993-11 | Cytotoxicity | Non-acute systemic toxicity | Did not show acute systemic toxicity in vivo (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Not an irritant (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Not a sensitizer (Pass) |
2. Sample size used for the test set and the data provenance
The document provides specific sample sizes for certain tests:
- Watertightness Test: 0/200 indicates a sample size of 200 gloves were tested for defects (with 0 failures).
- For other tests like dimensions, powder content, and physical properties, specific sample sizes are not explicitly stated in the summary table but are typically defined by the ASTM/ISO standards referenced.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it would be from manufacturing lots of the "Jiangsu Standard Health Co.,Ltd" gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This is a physical device. Ground truth is established by standardized physical and chemical tests, not expert interpretation of outputs.
4. Adjudication method for the test set
N/A - Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or AI studies. For a physical device, compliance is determined by meeting the specified limits of the test standards.
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
N/A - This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on the physical and chemical properties of the gloves, as measured and evaluated according to internationally recognized ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-10, ISO 10993-11, ISO 10993-5).
8. The sample size for the training set
N/A - This concept applies to AI/ML models. For a physical product, there isn't a "training set" in this context. Manufacturing processes are optimized, but this isn't typically referred to as a training set.
9. How the ground truth for the training set was established
N/A - As above, this is not applicable to a physical device in the AI/ML sense.
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