(35 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose 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, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00€4.
While the provided text describes a medical device (Powdered Vinyl Patient Examination Gloves) and its regulatory approval process, it is not an AI/ML device. Therefore, many of the requested fields related to AI/ML device testing (e.g., ground truth, MRMC study, training set) are not applicable.
Here's the information that can be extracted or deduced from the provided text, adapted for a non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ASTM Standard D-5250-00€4 requirements (Physical and Dimensions Testing) | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| FDA 1000 ml. Water Fill Test (Pinhole Requirements) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level 1, meeting these requirements." and "meets pinhole FDA requirements" |
| Primary Skin Irritation | "Primary Skin Irritation...testing was conducted with results showing no primary skin irritant reactions." |
| Skin Sensitization (Allergic Contact Dermatitis) | "Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing...no sensitization reactions." |
| Residual Powder (for "powdered" claim) | "A Residual Powder Test that based on ASTM D-6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our 'powdered' claims (contain no more than 10mg/dm4)." (Implies they meet this criterion). |
| General Biocompatibility Requirements | "meets...biocompatibility requirements" (No specific criteria detailed, but stated as met). |
| Labeling Claims (No special/hypoallergenic claims) | "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." and "meets...labeling claims as shown by data in Section 7." (The criterion is that any claims made are supported, and in this case, the lack of certain claims is a key aspect). |
2. Sample sized used for the test set and the data provenance
- ASTM D-5250-00€4 (Physical and Dimensions Testing): "Inspection level S-2, AQL 4.0." (This specifies a sampling plan for quality control rather than a fixed "test set" size.)
- FDA 1000 ml. Water Fill Test: "samplings of AQL 2.5, inspection level 1." (Again, a sampling plan.)
- Primary Skin Irritation and Skin Sensitization: The number of subjects is not specified, but it's a "testing" conducted.
- Residual Powder Test: Not specified beyond being "conducted."
Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. (China), based on specified ASTM standards and FDA requirements. The data is retrospective for the purpose of this 510(k) submission, as it describes tests already performed to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a physical medical device. The "ground truth" for its performance is determined by established physical and biological testing methods (e.g., water leak test, tensile strength tests, irritation tests) as per industry standards (ASTM) and regulatory requirements (FDA). There is no "ground truth" established by human experts in the way an AI diagnostic device would require.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Testing is based on objective measurements and established pass/fail criteria from standards. There is no human adjudication process involved in determining device performance against these physical and biological criteria.
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
Not applicable, as this is a physical medical device, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurement standards defined by ASTM (e.g., D-5250-00€4 for physical properties like dimensions, tensile strength, elongation, and D-6124-06 for residual powder) and regulatory compliance tests (e.g., FDA 1000 ml Water Fill Test for pinholes, biocompatibility testing for irritation/sensitization). There isn't "ground truth" in the diagnostic sense; rather, it's about meeting pre-defined performance specifications.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.