(117 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
This is a 510(k) summary for a medical device that is a disposable powder-free vinyl synthetic examination glove. The document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. It is not a study of an AI-powered diagnostic device, thus many of the requested categories are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Performance / Result |
|---|---|
| Physical and Dimensions Testing | Meets requirements for Physical and Dimensions Testing based on ASTM D5250-06. (Inspection level S-2, AQL 4.0) |
| Watertight Test (Pinhole) | Meets requirements based on ASTM D-5151-06. (Samplings of AQL 2.5, Inspection level I). Also stated as "meets pinhole FDA requirements". |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Residual Powder (for "powder-free" claim) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) based on ASTM D6124-06 for Starch at finished inspection. |
| Biocompatibility | Meets biocompatibility requirements (demonstrated by Primary Skin Irritation and Skin Sensitization testing). |
| ASTM D5250-06 Compliance | Conforms fully to ASTM D-5250-06 standard. |
| Applicable 21CFR References | Conforms fully to applicable 21CFR references. |
| Labeling Claims | Meets labeling claims (as shown by data in Section 7 - which presumably refers to the "powder-free" claim and the absence of a hypoallergenic claim, as well as the 1.00 ppm lead content disclosure). Note: No special labeling claims were made, and no hypoallergenic claim was made. |
| Lead Content Disclosure | The pigment contained in the manufacture of these gloves may contain 1.00 ppm of lead (This is a disclosure, not a performance metric to meet an acceptance criterion, but it is part of the overall compliance). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of units sampled is not explicitly stated but is determined by the AQL and inspection level.
- Watertight Test: Samplings of AQL 2.5, Inspection level I. The exact number of units sampled is not explicitly stated.
- Primary Skin Irritation and Skin Sensitization: The document does not specify the number of subjects or samples used for these biological tests.
- Residual Powder Test: Conducted at "finished inspection," but the sample size is not specified by AQL or number of units.
- Data Provenance: The report describes non-clinical laboratory testing performed by the manufacturer. The location of the manufacturer is Xuzhou, Jiangsu Province, China. The data would therefore be considered prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the testing of a physical medical device (gloves), not an AI diagnostic algorithm. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy is not applicable here. The "ground truth" for these tests are the objective measurements against established ASTM standards and FDA requirements.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The tests performed are objective, quantitative measurements against predefined standards.
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 document pertains to physical product testing of medical gloves, not an AI-powered diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on established industry standards (ASTM) and FDA regulatory requirements. These are objective measurements and biological test results, not expert consensus, pathology, or outcomes data in the diagnostic sense. For example, a glove either passes the watertight test according to the AQL, or it doesn't.
8. The Sample Size for the Training Set
Not applicable. This is not an AI-powered device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI-powered 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.