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510(k) Data Aggregation
(95 days)
Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Green, Orange, Violet and White Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
The provided document describes the performance testing and acceptance criteria for "Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile". This device is a Class I medical device and the submission focuses on its physical and chemical properties rather than an AI/ML algorithm. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Dimension | D 6319-00aE3 | Length ≥ 230 mm | Length = 246.77 mm |
| Width = 95 ± 10 mm | Width = 94.46 mm | ||
| Thickness: ≥ 0.05 mm (Finger, Palm, Cuff) | Thickness: Finger = 0.150 mm, Palm = 0.095 mm, Cuff = 0.082 mm | ||
| Physical Properties (Unaged) | D 6319-00aE3 | TS = 14 MPa | TS = 15.9 MPa |
| UE = 500 % | UE = 583.4 % | ||
| Physical Properties (Aged) | D 6319-00aE3 | TS = 14 MPa | TS = 22.3 MPa |
| UE = 400 % | UE = 569.2 % | ||
| Freedom from Pinholes | D 6319-00aE3, FDA 21 CFR 800.20 | Acc / Rej = 3 / 4 | 0 piece found |
| Moisture Content | In-house | < 0.8% | 0.67% |
| Powder Residue | D 6319-00aE3, D6124 - 01 | < 2.0 mg/glove | 0.84 mg/glove |
| Biocompatibility: Primary Skin Irritation in Rabbits | "Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 and ASTM F720-86" | Pass | Pass (Negative) |
| Biocompatibility: Dermal Sensitization | "Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 and ASTM F720-86" | Pass | Pass (Negative) |
2. Sample Size Used for the Test Set and Data Provenance
The document specifies some sample sizes for specific tests:
- Residual Powder: N = 5
- Moisture Content: N = 8
- Visual Inspection: Not explicitly stated as a count, but AQL levels (0.65 for critical, 2.5 for major, 4.0 for minor defects) imply sampling plans.
- Water Leak Test: G-1, AQL 1.5
- Physical Properties (General): S-2, AQL 4.0 and S-2, AQL 2.5 (Single Sampling)
The data provenance is from Indonesia, where the manufacturer (PT MAHAKARYA INTI BUANA) is located. The study is prospective in the sense that these are laboratory tests conducted on the manufactured product to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This device is a patient examination glove, and its performance is assessed through physical and chemical laboratory tests, not by human expert interpretation of data.
4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by objective laboratory measurements against defined standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This is not an AI/ML diagnostic or assistive device where human reader performance would be a factor.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical product (nitrile gloves), not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is established by international and national standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20, D6124 - 01, ISO standards for biocompatibility implicitly via "Consumer Product Safety Commission... and ASTM F720-86"). The performance measurements are directly compared against the numerical criteria specified in these standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for this device.
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