(252 days)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The device can be provided in non-sterile.
This document is a 510(k) Premarket Notification for "Medical Gloves" (K203622). It describes the device's characteristics, its intended use, and comparative testing against a predicate device (K180467) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device Under Evaluation: Medical Gloves (powder-free patient examination glove, nitrile latex compound, blue color)
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom from Holes - ASTM D5151 | Detection of holes that allow water leakage | Do not show droplet, stream or other type of water leakage (Meets ASTM D5151-19, AQL 2.5 Inspection, Level G-1, Accept at 5 failures, Reject at 6 failures). | No leakage (Meets ASTM D5151-19, AQL 2.5 Inspection, Level G-1, Accept at 5 failures, Reject at 6 failures). |
| Physical dimension - ASTM D6319 | Evaluate the glove physical dimension | Length: >220 mm (XS and S sizes), >230 mm (M, L and XL sizes) | |
| Width (±10mm): XS = 70mm, S = 80mm, M = 95mm, L = 110mm, XL = 120mm | |||
| Thickness at Finger (mm): All Sizes ≥ 0.05 mm | |||
| Thickness at Palm: All Sizes ≥ 0.05 mm | Length: Larger than 220mm for XS and S size, Larger than 230mm for M, L and XL sizes | ||
| Width: XS: within 70±10mm, S: within 80±10mm, M: within 95±10mm, L: within 110±10mm, XL: within 120±10mm | |||
| Thickness: Larger than 0.05mm (at finger and palm) | |||
| Physical requirement - ASTM D412 | Evaluate the physical requirement (Tensile Strength & Ultimate Elongation) | Before Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 500% | |
| After Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 400% | Before aging: Larger than 14Mpa and 500% | ||
| After aging: Larger than 14Mpa and 400% | |||
| Powder residue - ASTM D6124 | Evaluate the residue powder | Less than 2.0mg per glove. | Less than 2.0mg per glove. |
| Skin sensitization - ISO 10993-10 | Evaluated for the potential to cause delayed dermal contact sensitization | Magnusson and Kligman grade shall be less than control group. | No skin sensitization. |
| Skin irritation - ISO 10993-10 | Evaluated for the potential to cause skin irritation | No significant reaction than the control group. | No skin irritation. |
| Acute toxicity - ISO 10993-11 | Evaluated for acute systemic toxicity | No significant reaction than the control group. | |
| Animal death or abnormal behavior no more than two animals. | |||
| Body weight loss greater than 10% no more than 3 animals. (Note: Predicate device did not explicitly provide this data, but the proposed device showed no adverse effect.) | No acute toxicity. (Implies meeting all specified criteria). |
Study that Proves the Device Meets the Acceptance Criteria (Non-Clinical Testing):
The document explicitly states: "Non clinical tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the specific number of gloves or animals used for each test. However, it references specific ASTM and ISO standards (e.g., ASTM D5151-19, which specifies AQL levels and inspection levels for Freedom from Holes). These standards define appropriate sample sizes for testing compliance. For instance, ASTM D5151-19, AQL 2.5, Inspection Level G-1 means the sample size is determined by the lot size, but for the specifically mentioned acceptance/rejection criteria (Accept at 5 failures, Reject at 6 failures), it implies a certain sample size bracket within the standard.
- Data Provenance: The document does not specify the country of origin where the non-clinical tests were performed. It states the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, so it's reasonable to infer the tests were conducted in or overseen by this entity. The data is retrospective in the sense that the tests were performed, and the results are being reported as part of a premarket submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This section talks about the establishment of ground truth for a test set, typically relevant for AI/ML device evaluations. This document describes the evaluation of a physical medical device (gloves) against established performance standards. Therefore, the "ground truth" is based on objective, standardized test methods and their defined acceptance criteria. It is not based on expert consensus interpreting subjective data.
- The tests themselves are performed by trained personnel in a laboratory setting, but the document does not specify the number or qualifications of these individuals, as it's not a multi-reader study.
4. Adjudication Method for the Test Set
- Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests are objective and based on physical measurements and chemical analyses as per established 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 is not an AI/ML device that assists human readers. It is a physical medical device (gloves).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's ability to meet the specified performance criteria as tested in isolation according to the listed ASTM and ISO standards. The results table clearly indicates that the device met these criteria.
7. The Type of Ground Truth Used
- The ground truth used for this device's evaluation is primarily objective, standardized test results based on established international (ISO) and national (ASTM) consensus standards. These standards define measurable physical, chemical, and biological properties, along with clear acceptance/rejection criteria. For biocompatibility tests (skin sensitization, irritation, acute toxicity), the ground truth is established by the biological responses observed in the test models (e.g., animal models) according to the protocols defined in ISO 10993.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a "training set." The device itself is a manufactured product, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of 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.