(540 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
This document describes the FDA's decision regarding the substantial equivalence of Dahoon Plastic Company Limited's Powder Free Vinyl Patient Examination Gloves. It details the device, its intended use, and a comparison to a predicate device, focusing on non-clinical performance standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM D5250-06 and other standards) | Reported Device Performance (Dahoon Plastic Co., Ltd. gloves) |
|---|---|
| Device Description and Specifications: Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) |
| Dimensions - Length: Min. 230mm for all sizes (ASTM D5250-06) | Min. 230mm for all sizes |
| Dimensions - Width: Small 80-90mm, Medium 90-100mm, Large 100-110mm, X-Large 110-120mm (ASTM D5250-06) | Small 80-85mm, Medium 95-97mm, Large 102-108mm, X-Large 114-118mm |
| Dimensions - Thickness: Finger 0.05mm min., Palm 0.08mm min. (ASTM D5250-06) | Finger 0.05mm min., Palm 0.08mm min. |
| Physical Properties (Before/After aging): Elongation ≥300%, Tensile Strength ≥14MPa (ASTM D5250-06) | Elongation ≥300%, Tensile Strength ≥14MPa (Before/After aging) |
| Freedom from Pinholes: Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (AQL 2.5, Inspection Level I) | Meets ASTM D5151-06 (AQL 2.5, Inspection Level I) |
| Residual Powder: Meets ASTM D6124-06 (Results below 2mg) | Results generated values below 2mg of residual powder |
| Biocompatibility: Skin Irritation Dermal and Sensitization Studies meet ISO 10993-10:2002/Amd.1:2006 | Test article was not an irritant and not a sensitizer. Meets ISO 10993-10:2002/Amd.1:2006 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test (e.g., for width, thickness, tensile strength, pinholes, residual powder, or biocompatibility). Instead, it states that the device "meets requirements per ASTM D5250-06," "per ASTM D6124-06," "per 21 CFR 800.20," and "ISO 10993-10: 2002/Amd. 1:2006(E)." These ASTM and ISO standards define the testing methodologies, including sampling plans (e.g., AQL for pinholes).
The data provenance is not explicitly stated in terms of country of origin for the tests themselves, but the submitting company (Dahoon Plastic Co., Ltd.) is from China. The studies are described as non-clinical performance evaluations, which are typically retrospective in the sense that they are conducted on finished products or samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the "ground truth" for this medical device is based on standardized physical and chemical performance tests as defined by ASTM and ISO standards, rather than expert interpretation of complex data (like medical images). The "experts" in this context would be the technicians and engineers performing and interpreting the results of these standardized tests according to the specified protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there's subjectivity and potential for disagreement. For the specified physical and chemical tests of gloves, the results are quantitative and objective, determined by adherence to standardized test methods rather than expert consensus on subjective findings.
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. MRMC studies, especially those involving AI, are relevant for diagnostic imaging or other interpretation tasks where human readers make subjective judgments. This submission is for patient examination gloves, which are assessed through objective physical and chemical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (gloves), not an algorithm or software. Its performance is evaluated through direct measurement against established material and performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international and national consensus standards for medical gloves, specifically:
- ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This standard specifies dimensions, physical properties (tensile strength, elongation), and freedom from holes.
- ASTM D5151-06 (Reaffirmation 2011): Standard Test Method for Detection of Holes in Medical Gloves. This standard defines the water leak test and Acceptable Quality Limits (AQL) for pinholes.
- ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: FDA regulation regarding the water leak test for medical gloves.
- ISO 10993-10: 2002/Amd. 1:2006(E): Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
The "ground truth" is therefore objective, measurable, and defined by these widely accepted technical specifications and test methods.
8. The sample size for the training set
This is not applicable. The device is not an AI algorithm or a diagnostic tool that requires a "training set." It is a manufactured physical product.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.