Search Results
Found 2 results
510(k) Data Aggregation
(44 days)
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Disposable Medical Synthetic Nitrile Examination Gloves
The provided text is a U.S. Food and Drug Administration (FDA) 510(k) clearance letter for "Disposable Medical Synthetic Nitrile Examination Gloves." This document does not describe acceptance criteria for an AI/ML device or a study proving its performance.
Instead, it's a regulatory clearance for a physical medical device (gloves), confirming its substantial equivalence to previously marketed devices. The content focuses on regulatory compliance, such as registration, labeling, manufacturing practices, and adverse event reporting for this type of conventional device.
Therefore, I cannot extract the information required to answer your questions about acceptance criteria and a study proving the device meets those criteria, as no such information is present in the provided text. The questions you've posed (regarding tables of acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are relevant to the evaluation of AI/ML medical devices, not to the clearance of examination gloves.
Ask a specific question about this device
(114 days)
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Disposable Medical Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) summary for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASMT D6319-19) | Width: 80 mm (±10mm) (for small size) 95 mm (±10mm) (for medium size) 110 mm (±10mm) (for large size) Length: 220 mm (Minimum) (for small size) 230 mm (Minimum)(for medium, large size) Thickness: (for all sizes) Finger -0.05 mm (Minimum) Palm -0.05mm (Minimum) | Passed |
| Physical Requirements (Tensile Strength & Ultimate Elongation) (ASMT D6319-19) | Before Acceleration Aging: Tensile Strength (MPa): 14 (Minimum) Ultimate Elongation (%): 500 (Minimum) After Acceleration Aging: Tensile Strength (MPa): 14 (Minimum) Ultimate Elongation (%): 400(Minimum) | Passed |
| Freedom from Holes (Water Tight -1000 ml) (ASTM D6319-19 (ASTM D5151-11)) | AQL 2.5 | Passed |
| Residual Powder on Medical Gloves (ASMT D6319-19 (ASTM D6124-11)) | < 2.0 mg/glove | 0.6 mg/glove, Passed |
| Skin Irritation (ISO 10993-10) | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Skin Sensitization (ISO 10993-10) | Under the conditions of the study not a sensitizer. | Under the condition of the study not a sensitizer. |
| In Vitro Cytotoxicity (ISO 10993-5) | No more than grade 2 cytotoxicity at 100% extract concentration | Under the conditions of the cytotoxicity study, the extract of the test article showed mild cytotoxicity to L-929 cells and the cytotoxic level was 2. (This meets the acceptance criteria of "no more than grade 2 cytotoxicity"). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for physical dimensions, holes, or residual powder). However, the general statement mentions that the device "meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application," implying that the testing was conducted according to the sampling plans outlined in these standards.
The data provenance is not explicitly stated in terms of country of origin for the test data, nor whether it was retrospective or prospective. It is implied that these are prospective tests performed on the manufactured gloves as part of the submission process to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this document. The "ground truth" for this medical device (examination gloves) is established through adherence to recognized international standards (ASTM and ISO) for physical, chemical, and biological properties, not by expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, such as imaging AI applications. Examination gloves do not involve human diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurement against established international standards. Specifically:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-11: Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-11: Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization
- ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
Ask a specific question about this device
Page 1 of 1