(238 days)
Based upon 21 CFR Part 880.6250; "Patient examination glove" . A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coated, Tested for use with chemotherapy drugs.
The provided text describes Siam Sempermed Corp., Ltd.'s "Non-sterile, Powder-free Nitrile Examination Glove, Blue with Polymer coating Tested for use with chemotherapy drugs." The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission presents a table comparing the device's characteristics against recognized standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 6319-00a-05 | Meets |
| Physical Properties | ASTM D 6319-00a-05 | Meets |
| Freedom from pinholes | ASTM D 6319-00a-05 | Meets |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes |
Note: The document states that the device was "Tested for use with chemotherapy drugs," but specific acceptance criteria and performance data for chemotherapy drug permeation are not included in this table or description. This is a crucial omission for a device marketed with this claim.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the tests to evaluate dimensions, physical properties, freedom from pinholes, or powder-free residue. It also does not provide details on the sample size for the biocompatibility tests (number of rabbits or guinea pigs).
The data provenance is from Thailand, where Siam Sempermed Corp., Ltd. is located. The tests were presumably conducted as part of the device's development and regulatory submission. The document does not explicitly state whether the data is retrospective or prospective, but given it's for a 510(k) submission, it would generally be considered pre-market testing data generated specifically for this purpose.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the involvement of experts in establishing ground truth for the test set. The acceptance criteria are based on established ASTM (American Society for Testing and Materials) standards. Compliance with these standards is typically assessed through laboratory testing protocols, not through expert consensus on individual cases.
For biocompatibility, the assessment of "Primary Skin Irritation" and "Guinea Pig Sensitization" would be conducted by trained toxicologists or scientists. However, the exact number and qualifications of these experts are not provided.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or relevant here. The evaluation against ASTM standards and biocompatibility tests typically involves objective measurements and adherence to specified protocols, rather than expert adjudication of conflicting interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is not relevant for evaluating the performance of a medical glove against technical standards. MRMC studies are typically used to assess the effectiveness of diagnostic or screening devices where human interpretation plays a significant role, often comparing AI-assisted performance against human-alone performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was done in the sense that the device was tested independently against objective standards. The "performance" of the glove is its ability to meet the physical and biological requirements outlined in the ASTM standards. There is no "algorithm" involved in the glove's function, so the concept of an "algorithm only" performance doesn't apply here.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the established ASTM standards (e.g., ASTM D 6319-00a-05 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124-06 for powder-free residue) and biocompatibility test protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These standards and protocols represent a consensus on acceptable performance thresholds.
8. Sample Size for the Training Set
There is no "training set" in the context of this device. Medical gloves are manufactured products, and their performance is evaluated through physical and biological testing against established standards, not through training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
§ 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.