(42 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 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, Powder-Free (yellow) Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
This is a 510(k) summary for a medical device that is a Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Glove. This submission is for a Class I medical device, which generally means it poses a lower risk to patients and users and often relies on established performance standards rather than extensive clinical studies for approval.
The document describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the way one might describe for an AI/ML digital health product or more complex diagnostic device. For this type of glove device, acceptance criteria are tied to manufacturing standards and physical properties.
Here's the breakdown of the information requested, tailored to what's available for this specific medical device submission:
| Information Requested | Details for Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | |
| Acceptance Criteria | Reported Device Performance |
| ASTM-D-5250-92 Standard Compliance (Physical and Dimensions Testing) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. |
| FDA 1000 ml. Water Fill Test (Pinhole integrity) | Samplings of AQL 2.5, Inspection Level S-4, met requirements. |
| Biocompatibility (Primary Skin Irritation and Skin Sensitization) | Results showing no primary skin irritant or sensitization reactions. |
| Powder-Free Claim (USP Iodine Test for Starch) | Revealed passing results, adhering to USP Iodine test methodology. |
| 2. Sample size for test set and data provenance | The document does not specify a distinct "test set" sample size in the context of an AI/ML study. For the physical and performance tests, "samplings" were taken from production, with "Inspection Level S-2, AQL 4.0" for physical and dimensions, and "AQL 2.5, Inspection Level S-4" for the water fill test. This refers to statistical sampling plans used in quality control. The data provenance is implied to be from the manufacturer's internal testing as part of their production and quality assurance processes (China). The study is retrospective in the sense that these are manufacturing quality control tests conducted on finished products. |
| 3. Number of experts used to establish ground truth & qualifications | For this device (patient examination gloves), "ground truth" is established through standardized laboratory tests and adherence to established material and performance specifications (ASTM standards, FDA water fill test, USP tests). There isn't a team of human "experts" establishing a diagnostic ground truth in the way described for AI/ML. The "experts" are the laboratory technicians and quality control personnel performing the defined tests and interpreting the results against the established standards. No specific number or qualifications are provided beyond the implicit expertise in conducting these standard tests. |
| 4. Adjudication method for the test set | Not applicable in the context of diagnostic performance. Quality control for manufacturing relies on standardized test methods with pass/fail criteria. There isn't an "adjudication method" involving multiple human readers as in clinical image interpretation. |
| 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study | Not applicable. This is for a physical medical device (examination gloves), not an AI/ML system or diagnostic tool where human readers' performance would be evaluated. |
| 6. Standalone (algorithm only) performance study | Not applicable. This is for a physical medical device (examination gloves). There is no algorithm. |
| 7. Type of ground truth used | The ground truth is based on established industry standards and regulatory testing protocols: |
- ASTM Standard D5250-92 (for physical and dimensional properties)
- FDA 1000 ml. Water Fill Test (for pinhole integrity)
- Biocompatibility testing (Primary Skin Irritation and Skin Sensitization tests)
- USP Iodine Test (for powder-free claim verification). |
| 8. Sample size for the training set | Not applicable. This is for a physical medical device, not an AI/ML system requiring a training set. |
| 9. How the ground truth for the training set was established | Not applicable. This is for a physical medical 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.