Search Results

The Powder Free Grey Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The proposed device. Powder Free Grey Vinvl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The proposed is Powder Free Grey Vinyl Patient Examination Gloves, and includes variations of different size.

This document is a 510(k) premarket notification for disposable medical gloves. It compares a new device against a predicate device to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria Comparison:

1. Length: The proposed device lists a minimum length of ≥230mm, while the predicate states ≥240mm. The "Remark" for the proposed device states it "Complies with ASTM D5250," which would imply the 230mm is acceptable under the standard, despite being shorter than the predicate. This is a point of divergence that the FDA considered acceptable for substantial equivalence.
2. Width (XS vs S): The proposed device introduces an XS size (75mm width) not specified for the predicate. For equivalent sizes (S, M, L, XL), the widths match the predicate's tolerance.
3. Finger Thickness: The proposed device's minimum finger thickness (≥0.05 mm) is lower than the predicate (≥0.10 mm). Similar to length, the "Remark" states "Complies with ASTM D5250," indicating this lower thickness is still within standard limits.
4. Colorant: The color is different (Grey vs Blue). This is typically not a critical performance characteristic for gloves unless tied to a specific safety feature, and the document indicates "Complies with ASTM D5250."
5. Tensile Strength & Ultimate Elongation (Before & After Aging): The proposed device has lower minimum values for both tensile strength and ultimate elongation compared to the predicate. However, the "Remark" states "Complies with ASTM D5250," suggesting that these values, while lower than the predicate, still meet the requirements of the ASTM standard for medical application gloves. The FDA has accepted this as substantially equivalent.
6. Powder Content: The proposed device states "1.8 mg per glove." The predicate states "Meet the requirements of ASTM D5250." ASTM D6124-06 (Reaffirmation 2011) for residual powder is also listed as a standard the proposed device complies with, implying 1.8 mg per glove meets the standard's criteria.

2. Sample size used for the test set and the data provenance:

• The document describes "Bench tests" were conducted. It does not provide specific sample sizes for these tests (e.g., how many gloves were tested for length, width, thickness, holes, etc.).
• It refers to standards like ASTM D5250, ASTM D5151, ASTM D6124, and ISO 2859-1. ISO 2859-1 ("Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection") describes sampling methods for quality control, but the specific sampling plan (e.g., AQL level, lot size, sample size) used for these tests is not detailed in this summary.
• Data provenance: Not explicitly stated, but given the manufacturer (Zibo Flourish Trading Co., Ltd.) and the submission correspondent (Beijing Believe Tech. Service Co., Ltd.) are from China, it is highly probable the testing was conducted in China. The study appears to be a prospective test against specified standards for the new device.

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 and not provided for this type of medical device submission. The "ground truth" for glove performance is defined by adherence to recognized consensus standards (ASTM, ISO), not expert clinical adjudication or interpretation of complex medical data.

4. Adjudication method for the test set:

• Not applicable and not provided. Performance is assessed by direct measurement and testing against predefined quantitative thresholds in standards, not by an adjudication panel interpreting subjective data.

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 is a submission for disposable patient examination gloves, not an AI-powered diagnostic device. No MRMC study or AI component is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device (gloves), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for the performance of these gloves is based on established consensus standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 2859-1). For biocompatibility, it's based on the results of specific irritation and sensitization tests as outlined in ISO 10993-10.

8. The sample size for the training set:

• Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI. The manufacturing process itself is subject to quality control, which involves ongoing testing and process validation, but this is distinct from an AI training set.

9. How the ground truth for the training set was established:

• Not applicable, as there is no "training set" in this context.

Ask a specific question about this device