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510(k) Data Aggregation
(89 days)
The Disposable Medical Nitrile gloves 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 proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and a rolled rim at the cuff edge.
The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The document provided is a 510(k) summary for Disposable Medical Nitrile gloves (K213851) and thus describes non-clinical performance testing rather than a study for an AI-powered device. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted from the provided text, focused on the acceptance criteria and the tests performed for the Disposable Medical Nitrile gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference Standard) | Acceptance Criteria | Reported Device Performance (All three lots: 20210825B, 20210827A, 20210830A) | Conclusion |
|---|---|---|---|
| ASMT D6319-19 - Physical Dimensions (Width) | S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | S: 83-86mm (Lot B), 83-85mm (Lot A), 83-85mm (Lot A); M: 91-92mm (Lot B), 91-93mm (Lot A), 90-92mm (Lot A); L: 104-106mm (Lot B), 104-106mm (Lot A), 104-106mm (Lot A); XL: 112-114mm (Lot B), 111-113mm (Lot A), 112-115mm (Lot A) | Passed |
| ASMT D6319-19 - Physical Dimensions (Length) | S: ≥220 mm; M/L/XL: ≥230 mm | S: 234-236mm; M: 235-237mm; L: 237-239mm (Lot B,A), 237-240mm (Lot A); XL: 237-239mm | Passed |
| ASMT D6319-19 - Physical Dimensions (Thickness) | Finger: ≥0.05mm; Palm: ≥0.05mm | Finger: S/M: Pass at 0.11mm (Lot B, A), S/M/L: Pass at 0.11mm (Lot A), L/XL: Pass at 0.12mm (Lot B), M/L/XL: Pass at 0.12mm (Lot A), XL: Pass at 0.12mm (Lot A); Palm: S/M/L/XL: Pass at 0.08mm | Passed |
| ASMT D6319-19 - Physical Properties (Before Aging) | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥500% | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥500% | Passed |
| ASMT D6319-19 - Physical Properties (After Aging) | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥400% | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥400% | Passed |
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes | AQL 2.5 | Pass at AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) - Residual Powder | < 2.0 mg/glove | Lot 20210825B: Pass at 0.22 mg/glove; Lot 20210827A: Pass at 0.19 mg/glove; Lot 20210830A: Pass at 0.20 mg/glove | Passed |
| ISO 10993-10 - Skin Irritation | Under the conditions of study not an irritation | Under the conditions of study not an irritation | Passed |
| ISO 10993-10 - Skin Sensitization | Under the conditions of the study not a sensitization | Under the conditions of the study not a sensitization | Passed |
| ISO 10993-11:2017 - Acute Systemic Toxicity | Under the conditions of the study no systemic toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "three lots" (Lot 20210825B, Lot 20210827A, Lot 20210830A) for the performance testing. However, the specific sample sizes (number of gloves) tested within each lot for each test are not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified for these tests. This is a non-clinical device (gloves), so data provenance details like for AI/software would not typically apply.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is Disposable Medical Nitrile gloves, not an AI or diagnostic imaging device that requires expert ground truth establishment. The performance is based on physical and biological property testing against recognized standards.
4. Adjudication Method
This information is not applicable for the type of product and testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement
This information is not applicable as the device is Disposable Medical Nitrile gloves, not an AI or diagnostic imaging device. No MRMC study was mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This information is not applicable as the device is Disposable Medical Nitrile gloves, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by conformance to recognized international standards such as ASMT D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993-10, and ISO 10993-11:2017. These standards define the acceptable physical dimensions, tensile strength, elongation, freedom from holes, residual powder, and biocompatibility (skin irritation, sensitization, acute systemic toxicity).
8. The Sample Size for the Training Set
This information is not applicable as the device is Disposable Medical Nitrile gloves and does not involve AI or machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set for this type of device).
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