(134 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 hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00e4.
This 510(k) summary describes a patient examination glove and its performance testing. It focuses on demonstrating substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria in the context of an AI/software device. Therefore, many of the requested fields are not applicable to this document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM D5250-00E4) | Meets requirements (Inspection Level S-2, AQL 4.0) |
| Pinhole requirements (FDA 1000 ml. Water Fill Test, ASTM D-5151-99) | Meets requirements (samplings of AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Residual Powder Test (ASTM D6124-01 for Starch) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Physical and Dimensions Testing: Not explicitly stated, but performed with "Inspection Level S-2, AQL 4.0".
- Pinhole (Water Fill Test): Not explicitly stated, but performed with "samplings of AQL 2.5, Inspection Level I".
- Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
- Residual Powder Test: Not explicitly stated, but performed at "finished inspection".
- Data Provenance: Not specified, but likely from internal manufacturing and testing processes of Grand Work Plastics Products Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device (gloves), not an AI/software device where ground truth is established by experts. The performance is measured against physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described for this type of device testing.
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. This is for a physical medical device (gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device (gloves), there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by conformance to established industry standards (ASTM D5250-00E4, ASTM D-5151-99, ASTM D6124-01) and biocompatibility testing (Primary Skin Irritation and Skin Sensitization).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The "training" for a manufacturing process would be the ongoing quality control and process validation, which is not detailed in terms of sample size for this summary.
9. How the ground truth for the training set was established
Not applicable. There is no training set in the context of AI/ML for this device. The manufacturing process implicitly aims to produce gloves that meet the defined 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.