(61 days)
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTMD5151, and ASTMD5250. The proposed device is non-sterile.
This document is a 510(k) Pre-Market Notification for a Vinyl Patient Examination Glove, asserting substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device meets established standards for medical examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by recognized industry standards, and the reported device performance is presented as compliance with these standards or specific measured values.
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | ||
| Product Code | LYZ | LYZ |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Indications for Use | Disposable device for medical purposes, worn on examiner's hands to prevent contamination. | Same as predicate device. |
| Powdered/Powder-free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Surface Feature | Smooth | Smooth |
| Labeling Info | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile. | Same as predicate device. |
| Material | Vinyl | Vinyl |
| Label & Labeling | Meet FDA's Requirement | Meet FDA's Requirement |
| Dimensions | ||
| Length (XS, S, M, L, XL) | 230mm (XS, S), 235mm (M), 245mm (L, XL) min | 230mm (XS, S), 235mm (M), 245mm (L, XL) min |
| Width (XS, S, M, L, XL) | 80mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) +/-5mm | 80mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) +/-5mm |
| Thickness (Finger) | 0.05 mm min | 0.05 mm min |
| Thickness (Palm) | 0.08 mm min | 0.08 mm min |
| Performance | ||
| Colorant | N/A (Predicate had White, Blue, Yellow) | Clear, Non-Colored (Difference addressed by biocompatibility testing results) |
| Tensile Strength (Before Aging) | 15MPa, min (ASTM D5250) | 15MPa, min |
| Ultimate Elongation (Before Aging) | 380% min (ASTM D5250) | 380% min |
| Tensile Strength (After Aging) | 15MPa, min (ASTM D5250) | 15MPa, min |
| Ultimate Elongation (After Aging) | 380% min (ASTM D5250) | 380% min |
| Freedom from Holes | AQL=1.5 when tested with ASTMD5151 | Be free from holes when tested in accordance with ASTMD5151 AQL=1.5 |
| Powder Content | Meet the requirements of ASTM D6124 | 0.48 (This value implies it meets the requirements of ASTM D6124, which the predicate also met.) |
| Biocompatibility | ||
| Irritation | Not an irritant (ISO 10993-10) | Under the conditions of the study, not an irritant |
| Sensitization | Not a sensitizer (ISO 10993-10) | Under conditions of the study, not a sensitizer. |
| Cytotoxicity | Not cytotoxic (ISO 10993-5) | Under conditions of the study, not cytotoxic |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many gloves were tested for tensile strength, elongation, or freedom from holes). However, it refers to industry standards (ASTM D5151, ASTM D5250, ASTM D6124) which inherently define sampling plans for these tests. For instance, ASTM D5151 specifies an Acceptance Quality Limit (AQL) of 1.5, which implies a specific sampling size based on lot size for hole detection.
The data provenance is not explicitly stated in terms of country of origin for the testing itself, but given the submitter's address in China, it's reasonable to infer the testing took place there. The studies are retrospective in the sense that they are post-manufacturing tests performed on the finished product according to established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for Vinyl Patient Examination Gloves is primarily established by objective, quantifiable physical and chemical properties and biological safety assessments derived from standardized laboratory tests. There is no subjective assessment by medical experts required to determine if a glove has a specific tensile strength or is free from holes.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., image reading) where multiple experts might disagree on an assessment. For objective laboratory tests, the results are quantitative and do not require expert adjudication in this manner.
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 is not applicable. This is a submission for an examination glove, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessment of AI assistance for human readers are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective, quantitative laboratory measurements and biological testing results as defined by recognized consensus standards (ISO 10993-10, ISO 10993-5, ASTM D6124, ASTMD5151, ASTM D5250). For example:
- Physical Properties: Measured tensile strength and ultimate elongation against specified minimums.
- Freedom from Holes: Determined by standardized water leak tests (e.g., based on ASTM D5151).
- Powder Content: Measured gravimetrically according to ASTM D6124.
- Biocompatibility: Determined by in vitro and in vivo toxicology tests for irritation, sensitization, and cytotoxicity according to ISO 10993 standards.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning. The "training" for such devices involves adherence to manufacturing process controls and validated testing methods to ensure consistent product output.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this type of device. The ground truth for evaluating the device's performance is established by the specified requirements in the referenced international and ASTM 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.