(29 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 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, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-00.
This 510(k) summary is for a medical device (Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves) and does not describe AI/ML software. Therefore, many of the requested fields are not applicable.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Meets requirements for Physical and Dimensions Testing (Inspection Level S-2, AQL 4.0) per ASTM D5250-00. |
| Pinhole Requirements (Water Fill Test): | Meets requirements with samplings of AQL 2.5, Inspection Level I, per FDA 1000 ml. Water Fill Test. |
| Biocompatibility (Skin Irritation): | No primary skin irritant or sensitization reactions observed in Primary Skin Irritation and Skin Sensitization testing. |
| Biocompatibility (Sensitization): | No primary skin irritant or sensitization reactions observed in Primary Skin Irritation and Skin Sensitization testing. |
| ASTM Standard Compliance: | Conforms fully to ASTM-D-5250-00 standard. |
| CFR References: | Conforms fully to applicable 21 CFR references. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific sample size not provided, but these are standard sampling plans).
- Water Fill Test: Samplings of AQL 2.5, Inspection Level I. (Specific sample size not provided, but these are standard sampling plans).
- Biocompatibility Testing: Not specified whether samples were prospective or retrospective. No explicit country of origin provided for the test data, but the manufacturer is in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical product (gloves), and ground truth is established through standardized physical, chemical, and biological tests rather than expert interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, not for objective standardized testing of physical product properties.
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 device is a patient examination glove and does not involve AI or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a patient examination glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's performance was established through:
- Adherence to ASTM Standard D5250-00 (for physical and dimensional properties).
- Compliance with FDA 1000 ml. Water Fill Test requirements (for pinhole detection).
- Results from Primary Skin Irritation and Skin Sensitization testing (for biocompatibility).
These are objective, standardized laboratory and biological test results.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, and therefore no training set or associated ground truth establishment method for a training set is relevant.
§ 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.