(50 days)
The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91.
Here's an analysis of the provided text, focusing on the acceptance criteria and the studies mentioned for the "COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)":
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D 3578-91 & FDA) | COMFIT Glove Performance |
|---|---|---|
| Pinhole/Watertight (1000 ml) | S-4, AQL 4.0 (FDA 1000 ml watertight test implied) | Pass based on AQL of 2.5 (Better than specified AQL) |
| Length (mm) - Size S | min 230 | 249 |
| Length (mm) - Size M | min 230 | 249 |
| Length (mm) - Size L | min 230 | 249 |
| Palm width (mm) - Size S | 80 ± 10 | 85 |
| Palm width (mm) - Size M | 95 ± 10 | 96 |
| Palm width (mm) - Size L | 111 ± 10 | 105 |
| Thickness (mm) - Finger | min 0.08 | 0.22 |
| Thickness (mm) - Palm | min 0.08 | 0.16 |
| Physical Properties - Before Ageing (Tensile Strength MPa) | min 21 | 35.03 |
| Physical Properties - Before Ageing (Ultimate Elongation %) | min 700 | 868 |
| Physical Properties - After Ageing (Tensile Strength MPa) | min 16 | 29.85 |
| Physical Properties - After Ageing (Ultimate Elongation %) | min 500 | 826 |
| Powder Content | Not specified in ASTM D3578-91 (Implied by "Powder Free") | below 2 mg / glove |
| Protein Content | Not specified in ASTM D3578-91 (Implied by "Low Protein") | below 50 microgram / gram |
| Hypoallergenic Potential (Dermal Irritation/Sensitization) | No potential for eliciting dermal irritation or sensitization | No potential for eliciting either dermal irritation or sensitization |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Chemical Properties: The document refers to "Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test" but does not explicitly state a sample size for these tests. The AQL (Acceptance Quality Level) of 2.5 for watertight is mentioned, which implies a sampling plan was followed, but the specific number of gloves tested for each characteristic is not provided. The data provenance is not stated, but given the manufacturer is Malaysian, it's likely the testing occurred in Malaysia or a closely affiliated region.
- Hypoallergenic Claim: 200 Human subjects were used for the Modified Draize test. This was a prospective study as it involved testing on human subjects to assess the device's performance regarding the hypoallergenic claim. The country of origin for this specific trial is not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For Physical and Chemical Properties: The "ground truth" is established by the ASTM D 3578-91 standard and the FDA 1000 ml watertight test. These standards themselves are products of expert consensus and rigorous scientific methods, but individual experts are not explicitly named as providing ground truth for this specific device's test set. The tests are objective measurements against established criteria.
- For Hypoallergenic Claim: A "Modified Draize test" was performed. This type of test typically involves trained professionals (e.g., dermatologists, toxicologists, or technicians under their supervision) to observe and record skin reactions. However, the number and specific qualifications of the experts (e.g., dermatologists with X years of experience) who assessed the reactions in the 200 human subjects are not mentioned in the document.
4. Adjudication Method for the Test Set
- For Physical and Chemical Properties: Adjudication is not applicable in the sense of expert consensus for primary endpoints. The results are objective measurements against predefined thresholds in the ASTM standard. AQL (Acceptance Quality Level) indicates a statistical sampling plan for quality control rather than expert adjudication.
- For Hypoallergenic Claim: The document does not specify an adjudication method like 2+1 or 3+1. The Modified Draize test protocol itself would define how reactions are observed and interpreted. It's likely observations were made by trained personnel, but details on how conflicting interpretations (if any) were resolved are not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases with and without AI assistance. The device in question is an examination glove, and the studies described are related to its physical properties, chemical composition, and biocompatibility/allergenicity, not diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the device described. The "device" is a physical examination glove, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The type of ground truth used
- For Physical and Chemical Properties: The ground truth is based on objective measurements compared against pre-defined standards (ASTM D 3578-91 and FDA requirements).
- For Hypoallergenic Claim: The ground truth is established through clinical observation of human subjects in a controlled test (Modified Draize test) for the presence or absence of dermal irritation or sensitization.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product (examination gloves), not an AI algorithm, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for this physical device.
§ 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.