(310 days)
The Powder Free Nitrile Examination Gloves, Black 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.
The proposed device is a Powder Free Nitrile Examination Glove. The glove is available in one color: Black. The proposed device is non-sterile. The Powder Free Nitrile Examination Gloves, Black meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
The document discusses the substantial equivalence of "Powder Free Nitrile Examination Gloves, Black" (K161099) to a legally marketed predicate device. The study described focuses on non-clinical performance data to demonstrate that the device meets established acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10: Length ≥ 230mm, Width ≥ 95 ± 10mm | Meets ASTM D6319-10 Standard requirements: Minimal value for Length: 240 mm, Minimal value for Width: 95mm |
| Physical Properties | ASTM D6319-10: | Meets ASTM D6319-10 Standard requirements: |
| Tensile Strength (Before Aging) | ≥ 14 MPa | Minimal Value: 19.05 MPa |
| Tensile Strength (After Aging) | ≥ 14 MPa | Minimal Value: 16.25 MPa |
| Ultimate Elongation (Before Aging) | ≥ 500% | Minimal Value: 755% |
| Ultimate Elongation (After Aging) | ≥ 400% | Minimal Value: 625% |
| Thickness | ASTM D6319-10: Palm ≥ 0.05mm, Finger ≥ 0.05mm | Meets standard requirements: Palm ≥ 0.09mm, Finger ≥ 0.11mm |
| Biocompatibility | ISO 10993-10:2010 (Irritation and Skin Sensitization) | Under the condition of the Study – Not an irritant, Not a sensitizer |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06, AQL 2.5 | Meets 21 CFR 800.20 and ASTM D5151-06 Standard Requirements, Passes AQL 2.5 |
| Powder Residual | ASTM D6124-06: ≤ 2 mg/ glove | Meets ASTM D6124-06 Standard requirements: Minimal Value: 0.45 mg |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size in terms of number of gloves tested for each characteristic. However, the data represents non-clinical performance evaluations against established standards like ASTM and ISO. The provenance of the data would be internal testing conducted by the manufacturer, PT. Maja Agung Latexindo, which is located in North Sumatera, Indonesia. The study is retrospective in the sense that the test results are presented as already completed data to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The ground truth for the performance of the gloves is established by adherence to recognized international standards (ASTM and ISO), which detail testing methodologies and acceptance criteria. The tests themselves are standardized procedures, so the "experts" would be the technicians or engineers conducting these tests in a laboratory setting, ensuring the methods are followed correctly.
4. Adjudication Method for the Test Set:
This is not applicable as the study involves standardized physical and chemical tests rather than expert review or adjudication of subjective interpretations. The outcomes are objective measurements against predefined limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data, which is not the case for examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this question is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth used for determining the device's performance is objective measurements derived from established international standards (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10:2010). These standards define the acceptable range for various physical, chemical, and biological properties of examination gloves.
8. The Sample Size for the Training Set:
This question is not applicable. The device is not an AI or machine learning model that requires a training set. The "training" here refers to the manufacturing process and quality control measures to ensure consistent product attributes.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable for the reasons stated above. The "ground truth" for the manufacturing process is established by internal quality control procedures and adherence to the specifications outlined in the referenced standards.
§ 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.