(241 days)
Powder-Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
This document is a 510(k) summary for the Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than a traditional study proving a device meets specific acceptance criteria for a new clinical claim. Therefore, the information provided will be structured to align with the content of this regulatory submission.
1. Acceptance Criteria and Reported Device Performance (Summary of Equivalence to Predicate)
The device demonstrates substantial equivalence by meeting the same ASTM standards and regulatory requirements as the predicate device.
| Acceptance Criteria (Set by ASTM Standards and FDA Regulations) | Reported Device Performance (Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves) | Result of Comparison to Predicate |
|---|---|---|
| Physical Dimensions: | ||
| Length (≥230mm min.) | Meets ASTM D5250-06 (Reapproved 2011) - ≥230mm min. for all sizes | Substantially equivalent |
| Width (Small: 80-90mm, Medium: 90-100mm, Large: 100-110mm, X large: 110-120mm) | Meets ASTM D5250-06 (Reapproved 2011) - Matches predicate's width specifications for all sizes | Substantially equivalent |
| Thickness (Finger: ≥0.05mm min., Palm: ≥0.08mm min.) | Meets ASTM D5250-06 (Reapproved 2011) - Finger: ≥0.05mm min., Palm: ≥0.08mm min. | Substantially equivalent |
| Physical Properties (Before/After Aging): | ||
| Elongation (≥300%) | Meets ASTM D5250-06 (Reapproved 2011) - Elongation ≥300% | Substantially equivalent |
| Tensile Strength (≥14MPa) | Meets ASTM D5250-06 (Reapproved 2011) - Tensile Strength ≥14MPa | Substantially equivalent |
| Freedom from Pinholes: | ||
| Meets 21 CFR 800.20 | Meets 21 CFR 800.20 | Substantially equivalent |
| Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Meets ASTM D5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) - Inspection Level I, AQL 2.5 | Substantially equivalent |
| Residual Powder: | ||
| Meets ASTM D6124-06 (Reaffirmation 2011) | ASTMD6124-06 (Reaffirmation 2011) - Results generated values below 2mg of residual powder | Substantially equivalent |
| Material Composition: | ||
| PVC | PVC | Substantially equivalent |
| Donning Powder (e.g., PU/Polyurethane) | Polyurethane | Substantially equivalent |
| Biocompatibility: | ||
| Not an irritant/sensitizer (Meets ISO 10993-10) | Not an irritant/sensitizer (Meets ISO 10993-10 Third Edition 2010-08-01) | Substantially equivalent |
| Intended Use: | ||
| Non-sterile, disposable, medical purposes, worn on hand/finger to prevent contamination between patient and examiner | Non-sterile, disposable, medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a typical clinical study. The performance characteristics for the Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves were evaluated against established ASTM standards (D5250, D5151, D6124) and FDA regulations (21 CFR 800.20).
- Sample sizes for testing: The specific sample sizes used for each test (e.g., tensile strength, pinholes, residual powder) are not explicitly stated in this summary. These would typically be defined within the referenced ASTM standards.
- Data Provenance: The device is manufactured by Ideal Plastic Co., Ltd. in China. The testing would have been conducted by or for the manufacturer, likely in China or by certified laboratories. The data itself is "nonclinical" and laboratory-based, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this 510(k) submission. This type of submission relies on conformity to established engineering and material standards, and bench testing, rather than expert-derived ground truth from complex medical images or clinical scenarios. The "ground truth" here is the adherence to the specifications outlined in the ASTM standards and FDA regulations, verified through standardized testing methods.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a conformity assessment based on standardized tests, not an expert-driven adjudication process.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a Class I patient examination glove, and its substantial equivalence is demonstrated through physical and chemical property testing, not through MRMC studies comparing human reader performance. Its function is as a barrier, not an interpretative tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device (glove), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" is defined by the established performance specifications within the referenced ASTM standards (D5250-06, D5151-06, D6124-06) and FDA regulations (21 CFR 800.20), along with the biocompatibility requirements of ISO 10993-10. The device's performance is compared directly to these objective, quantitative standards.
8. Sample Size for the Training Set
Not applicable. This is a physical device, and the concept of a "training set" for an algorithm does not apply. The manufacturing process is controlled to ensure consistent product attributes, not to "train" a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as point 8.
§ 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.