(78 days)
Powder Free Polymer Coated Patient Examination Gloves are disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Powder Free Polymer Coated Patient Examination Gloves
This document is a 510(k) premarket notification from the FDA, specifically concerning a medical device: Royal Imperial Powder Free Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less).
The document does not contain the detailed study information needed to answer your request about acceptance criteria and device performance as if it were a software or AI device. This is a regulatory clearance letter for a physical medical glove. The type of "study" for a glove would involve physical testing and chemical analysis, not the kind of AI/software performance studies you're asking about.
Therefore, I cannot extract the information required for the table and subsequent questions (sample sizes, expert qualifications, MRMC studies, standalone performance, training set data) from this document.
However, I can infer some "acceptance criteria" for this type of device based on general FDA requirements for examination gloves, even though the specific numerical criteria are not in this letter.
Inferred Acceptance Criteria for Examination Gloves (General, Not from this document):
- Protein Content: The claim in the device name "50 Micrograms or Less" is a key acceptance criterion for latex gloves intended to mitigate allergic reactions. This is typically measured through recognized testing standards.
- Physical Integrity/Barrier Protection: This involves testing for pinholes and leaks (e.g., water leak test, air inflation test).
- Tensile Strength and Elongation: To ensure the gloves do not break easily during use.
- Dimensions (Length, Width, Thickness): To ensure proper fit and coverage.
- Biocompatibility: Tests for skin irritation and sensitization.
- Sterility (if claimed): Absence of microorganisms, verified through sterilization validation.
- Powder Residue (if powder-free): A specific limit on residual powder.
Since the provided document is a 510(k) clearance letter, it confirms that the device met the necessary criteria for substantial equivalence to a predicate device, as determined by the FDA. The specific studies and their results would be detailed in the manufacturer's 510(k) submission, which is not this letter.
To directly answer your prompt based only on the provided text, many fields will be "Not Applicable" or "Information Not Provided".
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred for Examination Gloves) | Reported Device Performance (Inferred from 510(k) Clearance) |
|---|---|
| Protein Content (e.g., ≤ 50 µg/g of glove) | Claimed as "50 Micrograms or Less" and accepted by FDA for substantial equivalence. |
| Physical Integrity (e.g., AQL for pinholes) | Met standards for substantial equivalence. |
| Tensile Strength & Elongation | Met standards for substantial equivalence. |
| Dimensions | Met standards for substantial equivalence. |
| Biocompatibility | Met standards for substantial equivalence. |
| Powder Residue (for powder-free claim) | Met standards for substantial equivalence. |
2. Sample sized used for the test set and the data provenance
- Information Not Provided in the document. For physical medical devices like gloves, testing involves batches, and the sample size would depend on the specific ISO or ASTM standards applied (e.g., AQL sampling plans).
- Data Provenance: The manufacturer is Koon Seng Sdn. Bhd. in Muar, Johor, MALAYSIA. The testing would likely have originated in Malaysia or a certified lab approved by the manufacturer. It would be prospective testing of manufactured batches.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the context of this device. "Ground truth" in this context refers to physical/chemical properties measured objectively against established standards, not interpretation by human experts in the way AI/software devices are evaluated. The "experts" would be laboratory technicians and engineers performing these tests, and regulatory reviewers from the FDA.
4. Adjudication method for the test set
- Not applicable in the context of this device. Adjudication typically refers to resolving discrepancies in expert interpretations. For physical testing, results are objective measurements. Regulatory review by the FDA (e.g., via a 510(k) process) serves as the "adjudication" or approval of the submission based on the provided 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 device is an examination glove, not an AI or software device that "human readers" would interact with in this manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an examination glove, not an algorithm.
7. The type of ground truth used
- Objective Physical and Chemical Measurements: For gloves, ground truth is established through standardized laboratory tests that measure physical properties (e.g., tensile strength, elongation, dimensions, leak resistance) and chemical properties (e.g., protein content, powder residue, biocompatibility). These are defined by international standards (e.g., ASTM, ISO).
8. The sample size for the training set
- Not applicable. This device is an examination glove and does not involve a "training set" in the machine learning sense. The manufacturing process involves quality control and process validation, which might involve data collection from production runs, but it's not a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an algorithm.
§ 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.