(101 days)
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.
The provided document is a 510(k) Pre-market Notification for Vinyl Examination Gloves. This type of device is a Class I medical device, which falls under general controls and does not typically require extensive clinical data or complex performance studies like those seen for higher-risk devices (e.g., AI/ML-driven diagnostic tools).
Therefore, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of an AI/ML device, as requested in the prompt, are not applicable to this document.
For Vinyl Examination Gloves, "acceptance criteria" primarily relate to material properties, performance standards for physical integrity, and biocompatibility, rather than diagnostic accuracy or human performance improvement. The "study" proving these criteria are met consists of non-clinical, laboratory-based tests.
Here's how to interpret the document in the context of the prompt, while acknowledging the fundamental difference in device type:
Device: Vinyl Examination Gloves (White, Blue, Yellow)
Submission Number: K163168
Predicate Device: K150224 Blue Vinyl Examination Gloves Powder Free
Basis for "Acceptance Criteria" and "Proof":
For this Class I device, "acceptance criteria" are defined by recognized consensus standards to ensure the gloves are safe and effective for their intended use. "Proof" is provided through non-clinical bench testing demonstrating compliance with these standards and comparability to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, specific "performance" metrics for diagnostic accuracy are not relevant. Instead, the performance metrics relate to the physical and biological characteristics of the gloves. The "acceptance criteria" are the minimum requirements set by the ASTM and ISO standards, and the "reported device performance" indicates that the proposed device met or exceeded these.
Table 1: Acceptance Criteria (Referenced Standards) and Reported Device Compliance
| Metric / Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance** |
|---|---|---|
| Product Code | LYZ (Predicate device) | LYZ |
| Regulation No. | 21 CFR 880.6250 (Predicate device) | 21 CFR 880.6250 |
| Class | I (Predicate device) | I |
| Intended Use | Defined as preventing contamination | "A disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner." (Same as predicate) |
| Powder/Powder Free | Powder Free (Predicate device) | Powdered free |
| Design Feature | Ambidextrous (Predicate device) | ambidextrous |
| Labeling | Consistent with predicate / FDA recommendations | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile (Same as predicate) |
| Dimensions (Length) | ASTM D5250 (e.g., L: 230mm min for Proposed; S: 240mm min for Predicate) | Proposed: XS: 230mm, S: 230mm, M: 235mm, L: 245mm, XL: 245mm (min) |
| Predicate: S: 240mm, M: 240mm, L: 240mm, XL: 240mm (min) | ||
| Analysis 1: Proposed device meets ASTM D5250 specifications despite size differences with predicate. | ||
| Dimensions (Width) | ASTM D5250 (e.g., L: 105 ± 5 mm) | Proposed: XS: 80mm, S: 85mm, M: 95mm, L: 105mm, XL: 115mm ($\pm 5$ mm) |
| Predicate: S: 85mm, M: 95mm, L: 105mm, XL: 115mm ($\pm 5$ mm) | ||
| Dimensions (Thick.) | ASTM D5250 (Finger/Palm min) | Proposed: Finger: 0.05mm min, Palm: 0.08mm min |
| Predicate: Finger: 0.10mm min, Palm: 0.08mm min | ||
| Physical Prop. (Tensile Strength) | Before Aging: 11 MPa min (ASTM D5250) | Proposed: 15 MPa, min |
| Predicate: 13 MPa, min | ||
| Both comply with ASTM D5250 (11 MPa min) | ||
| Physical Prop. (Ultimate Elongation) | Before Aging: 300% min (ASTM D5250) | Proposed: 380% min |
| Predicate: 400% min | ||
| Both comply with ASTM D5250 (300% min) | ||
| Physical Prop. (Tensile Strength) | After Aging: 11 MPa min (ASTM D5250) | Proposed: 15 MPa, min |
| Predicate: 13 MPa, min | ||
| Both comply with ASTM D5250 (11 MPa min) | ||
| Physical Prop. (Elongation) | After Aging: 300% min (ASTM D5250) | Proposed: 380% min |
| Predicate: 400% min | ||
| Analysis 3: Proposed device meets ASTM D5250 specifications despite differences with predicate. Both comply with ASTM D5250 (300% min). | ||
| Freedom from Holes | ASTM D5151, AQL 1.5 | "Be free from holes when tested in accordance with ASTM D5151 AQL 1.5" |
| (Predicate uses AQL 2.5/Inspection Level G-I; Proposed is stricter AQL) | ||
| Powder Content | Less than 2mg per glove (ASTM D5250) | White: 0.50 mg per glove, Blue: 0.60 mg per glove, Yellow: 0.70 mg per glove |
| All meet ASTM D5250 requirement. | ||
| Biocompatibility (Irritation) | Not an irritant (ISO 10993-10) | "Under the conditions of the study, not an irritant" |
| Comply with ISO 10993-10 | ||
| Biocompatibility (Sensitization) | Not a sensitizer (ISO 10993-10) | "Under conditions of the study, not a sensitizer." |
| Comply with ISO 10993-10 |
Footnote: The acceptance criteria are largely based on the predicate device's performance and/or compliance with the specified ASTM/ISO standards. Performance shows general compliance and sometimes superior values (e.g., tensile strength for proposed device).
2. Sample sized used for the test set and the data provenance
- Sample Size: The document does not specify the exact numerical sample sizes for each non-clinical test (e.g., how many gloves were tested for holes or tensile strength). However, it refers to standards like ISO 2859-1 (Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection) for sampling, which implies that appropriate statistically relevant sample sizes were used according to these standards. For biocompatibility, typical animal testing or in-vitro tests are used, but specific numbers are not given.
- Data Provenance: The tests were conducted by the manufacturer, Hebei Hongtai Plastic Products Company Limited, in China ("Hebei Province 055250, China"). The data is retrospective as it was collected prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a Class I device like examination gloves, "ground truth" as it pertains to medical diagnosis by experts (e.g., radiologists) is not relevant. The "ground truth" for the performance of the gloves is established by the accepted scientific and engineering principles codified in the ASTM and ISO standards (e.g., a hole is a hole as defined by the test method, tensile strength is measured quantitatively). These standards are developed and agreed upon by expert committees in their respective fields (materials science, biocompatibility, etc.).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no human experts are performing diagnoses or interpretations to establish ground truth for this device, an adjudication method is irrelevant. The tests are objective, quantitative measurements against predefined criteria.
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
- No. An MRMC study is not applicable to a Class I physical device like examination gloves. These studies are typically performed for diagnostic devices (especially AI/ML-driven ones) where human performance (e.g., agreement with ground truth, detection rates) is a key outcome.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, but not in the context of an algorithm. The "standalone performance" of the gloves refers to their physical and biocompatibility characteristics when tested independently according to the specified standards. This is what the non-clinical tests (e.g., for holes, tensile strength, irritation) prove. It's the device's inherent properties, without human interpretation or intervention in its diagnostic capability because it has none.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these gloves is objective, measurable criteria defined by consensus standards:
- Physical Parameters: Measurements of length, width, thickness, tensile strength, elongation, and powder content are quantitative and directly measured by standard methods (e.g., ASTM D5250).
- Integrity: "Freedom from holes" is determined by a standardized test method (ASTM D5151) that objectively detects leaks.
- Biocompatibility: "Non-irritant" and "non-sensitizer" status is determined by standardized biological evaluation tests (ISO 10993-10), typically involving in-vitro and/or animal testing, not human expert consensus on a subjective finding.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is manufactured based on a design and then tested against standards.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding "ground truth" establishment process 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.