(103 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 upon 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, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided text describes a 510(k) premarket notification for "Zibo Litong Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free." This is a Class I medical device (patient examination glove), which, by its nature, does not typically involve AI components or complex diagnostic algorithms. Therefore, the specific questions regarding AI performance metrics, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this type of medical device submission.
The acceptance criteria and studies focus on the physical properties and biocompatibility of the gloves, ensuring they meet established ASTM standards and FDA requirements for patient examination gloves.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ASTM D5250-06 (Physical and Dimensions Testing) | Meets all requirements (Inspection Level S-2, AQL 2.5) |
| FDA 1000 ml Water Fill Test (Pinhole integrity) | Meets requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| Powder-Free Claim (≤ 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Overall Conformity | Conforms fully to ASTM-D-5250-06 standard and applicable 21 CFR references (e.g., 21 CFR 880.6250) |
| Biocompatibility | Meets biocompatibility requirements |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5. (Specific sample size not explicitly stated, but determined by ASTM D5250-06 and the AQL).
- Water Fill Test: AQL 2.5, Inspection Level I. (Specific sample size not explicitly stated, but determined by FDA requirements and the AQL).
- Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but implied to be conducted on relevant biological samples.
- Data Provenance: The device is manufactured by Zibo Litong Plastic Products Co., Ltd. in Zibo, China. The testing was conducted to meet US FDA and ASTM standards. The text does not specify the country of origin for the "data" from skin irritation/sensitization tests, but typically, these tests are performed in accredited labs. The studies are essentially "retrospective" in the sense that the testing was performed on manufactured gloves to demonstrate compliance for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The "ground truth" for glove performance is established by objective physical and chemical testing against defined standards (ASTM and FDA). It does not involve expert readers or diagnostic interpretations.
4. Adjudication method for the test set
- This question is not applicable. Adjudication is relevant for subjective assessments, primarily in clinical trials or image interpretation. Glove testing involves objective measurements.
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
- This question is not applicable. This device is a medical glove, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. There is no AI algorithm in this device.
7. The type of ground truth used
- For physical and performance characteristics: Objective measurements against defined industry standards (ASTM D5250-06) and regulatory requirements (FDA 1000 ml Water Fill Test, chemical analysis for powder content).
- For biocompatibility: Results from primary skin irritation and skin sensitization tests.
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of an AI model for this device. The manufacturing process is controlled to consistently produce gloves that meet the specifications, but there isn't a machine learning training phase.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
§ 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.