(44 days)
A 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
The provided text is a 510(k) summary for a medical device: "Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy." Based on the provided document, the device is a Class I patient examination glove. The document describes non-clinical tests to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | |
| ASTM-D-6319-00aE3 (General Glove Standard) | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 4.0." And "Syntex Healthcare Products Co., Ltd. Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy conform fully to ASTM-D-6319-00a€3 standard..." |
| Pinhole / Water Leak Test: | |
| FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level G-1) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level G-1, meeting these requirements." And "...meets pinhole FDA requirements." |
| Biocompatibility (Skin Irritation/Sensitization): | |
| Primary Skin Irritation and Skin Sensitization testing | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." And "...biocompatibility requirements..." |
| Powder Residue (for "powder-free" claim): | |
| ASTM D6124-01 for Starch (no more than 2 mg powder per glove) | "A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 2 mg powder per glove)." |
| Chemotherapy Permeation (Implied based on device name, but not explicitly detailed in the summary) | The device is named "Tested for Chemotherapy," implying specific testing for this use. However, the 510(k) summary does not explicitly detail the acceptance criteria or results for chemotherapy permeation testing. It only states that the device "conform[s] fully to ASTM-D-6319-00a€3 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements. biocompatibility requirements and labeling claims as shown by data in Section 7." The lack of specific details for chemotherapy testing in Section 7 (Discussion of Non-Clinical tests) and Section 8 (Discussion of Clinical Tests) is a notable omission in this summary regarding the "Tested for Chemotherapy" aspect. |
2. Sample Size Used for the Test Set and the Data Provenance
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (This refers to a sampling plan for quality control rather than a specific sample size for a "test set" in an AI/Software context).
- FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level G-1. (Again, a sampling plan for quality control).
- Biocompatibility (Skin Irritation/Sensitization), Residual Powder Test: No specific sample sizes are mentioned for these tests, only that testing was "conducted."
- Data Provenance: Not applicable in the context of this device (a physical glove). The tests are performed on manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device (a physical examination glove). Ground truth in this context is established by physical measurements and laboratory analyses against defined standards, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessment.
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
This information is not applicable to this type of device. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI for assistance. This device is a physical glove.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this type of device. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a physical glove.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on defined physical and chemical standards as outlined in relevant ASTM standards and FDA requirements. This includes:
- Physical dimensions and tensile strength (ASTM-D-6319-00aE3)
- Barrier integrity (FDA 1000 ml. Water Fill Test for pinholes)
- Biocompatibility (Primary Skin irritation and Skin Sensitization testing via laboratory methods)
- Powder content (ASTM D6124-01)
- (Implied: Chemotherapy permeation data based on the device name, but methods/results are not detailed in this summary).
8. The Sample Size for the Training Set
This information is not applicable to this type of device. Training sets are relevant for machine learning algorithms, not for physical products like gloves.
9. How the Ground Truth for the Training Set was Established
This information is not applicable to this type of device, as it does not involve a training set for an algorithm.
§ 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.