(53 days)
The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) 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 clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
The provided document is a 510(k) summary for a medical device: "Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical benefit. Therefore, the information provided relates to performance against recognized standards and comparison to predicates, not a traditional clinical study with human readers or training sets as might be seen for AI algorithms.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents performance information in Tables 2, 3, and 4 (starting on page 6), comparing the proposed device to predicate devices and referencing ASTM and ISO standards for acceptance criteria.
| Acceptance Criterion (Standard Ref.) | Proposed Device Performance (K182043) | Predicate Device (K163168) Performance | Predicate Device (K180849) Performance |
|---|---|---|---|
| Dimensions (Table 2) | |||
| Length, mm (min) | 240 | 230 (XS, S), 235 (M), 245 (L, XL) | 230 (S), 235 (M), 245 (L, XL) |
| Width, mm (±5) | 80 (XS), 85 (S), 95 (M), 105 (L), 115 (XL) | 80 (XS), 85 (S), 95 (M), 105 (L), 115 (XL) | 85 (S), 95 (M), 105 (L), 115 (XL) |
| Finger Thickness, mm (min) | 0.07 | 0.05 | 0.05 |
| Palm Thickness, mm (min) | 0.08 | 0.08 | 0.08 |
| Physical Properties (Table 3) | |||
| Before Aging (ASTM D5250) | |||
| Tensile Strength, MPa (min) | 15 | 15 | 15 |
| Ultimate Elongation, % (min) | 350 | 380 | 380 |
| After Aging (ASTM D5250) | |||
| Tensile Strength, MPa (min) | 15 | 15 | 15 |
| Ultimate Elongation, % (min) | 350 | 380 | 380 |
| Freedom from Holes (ASTM D5151) | Be free from holes, AQL=1.5 | Be free from holes, AQL=1.5 | Be free from holes, AQL=1.5 |
| Powder Content (ASTM D6124) | 0.33 mg | Meet ASTM 5250 requirements | Meet ASTM 5250 requirements |
| Biocompatibility (Table 4) | |||
| Irritation (ISO 10993-10) | Not an irritant | Not an irritant / Comply with ISO 10993-10 | Comply with ISO 10993-10 |
| Sensitization (ISO 10993-10) | Not a sensitizer | Not a sensitizer / Comply with ISO 10993-10 | Comply with ISO 10993-10 |
| Cytotoxicity (ISO 10993-5) | Did not show potential toxicity to L-929 cells | / | Comply with ISO 10993-5 |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Meet FDA's Requirements |
Differences noted and addressed:
- Length (Analysis 1): The proposed device has a different length than the predicate, but test results according to ASTM 5250 showed it meets standard requirements.
- Colorant (Analysis 2): The proposed device is clear/non-colored, while one predicate is white, blue, or yellow. The submission argues that color difference does not affect safety and effectiveness, supported by biocompatibility testing (ISO 10993-5 and ISO 10993-10).
- Ultimate Elongation (Analysis 3): The proposed device has a different ultimate elongation value than the predicate, but test results according to ASTM 5250 showed it meets standard requirements.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size for each specific test (e.g., number of gloves tested for tensile strength, freedom from holes, etc.). However, it refers to standards such as ISO 2859-1:1999 ("Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection"), which would dictate the appropriate sample sizes for quality control testing based on lot size and AQL levels. For example, for "Freedom from Holes," an AQL of 1.5 is specified, which implies a specific sampling plan from ISO 2859-1.
- Data Provenance: The tests were conducted by the "HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD." in China, as indicated by the sponsor's identification. These are non-clinical (bench) tests supporting the device's conformance to established industry standards. The data is thus generated internally by the manufacturer for the purpose of this submission.
- Retrospective or Prospective: These are laboratory/bench tests that are inherently "prospective" in the sense that they are performed on manufactured product samples to demonstrate compliance with specifications.
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 submission. The "ground truth" for medical gloves is established by predefined engineering specifications and performance criteria codified in international standards (e.g., ASTM D5250, ISO 10993 series). The tests are evaluated against these objective numerical or qualitative criteria, not by expert consensus in a clinical context.
4. Adjudication method for the test set:
Not applicable. This device is evaluated against objective technical standards (ASTM, ISO). There is no "adjudication" of expert opinions for a test set in this context.
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 submission is for single-use medical examination gloves, which are not AI-enabled devices and do not involve human readers interpreting diagnostic images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that it meets physical and biocompatibility specifications on its own, without requiring human interpretation for its intended function.
7. The type of ground truth used:
The "ground truth" for this device's performance is defined by the objective, measurable parameters and criteria stipulated in the referenced international standards:
- ASTM D6124 (Residual Powder)
- ASTM D5151 (Detection of Holes)
- ASTM D5250 (Poly(vinyl chloride) Gloves for Medical Application)
- ISO 10993-10 (Irritation and Skin Sensitization)
- ISO 10993-5 (In Vitro Cytotoxicity)
- ISO 2859-1 (Sampling Procedures)
These standards specify the methods for testing and the acceptable limits or qualities (e.g., minimum tensile strength, maximum powder content, AQL for freedom from holes, non-irritant/non-sensitizer for biocompatibility).
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI 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.