(419 days)
A powdered surgeon's glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Class I Surgeon's Gloves (Powdered) 79 KGO that meets all the requirements of ASTM D 3577-00. A powdered surgeon's glove is a disposable device made of natural rubber lates that bears powder to facilitate donning and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
This document (K031368) is a 510(k) premarket notification for Powdered Latex Surgeon's Gloves. It is a declaration of substantial equivalence to a predicate device, not a study demonstrating performance against detailed acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this document. This K number pertains to a Class I device, which typically involves fewer rigorous testing requirements than higher-risk devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the way you might expect for a new, complex AI or imaging device. The "performance" here is primarily compliance with a recognized standard.
Here's the information that can be extracted or reasonably inferred from the provided text, along with what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D 3577-00 requirements | Device meets all requirements of ASTM D 3577-00 (implied by "complies with ASTM D3577-00" in predicate device description) |
- Note: The document states the device "meets all the requirements of ASTM D 3577-00". This ASTM standard defines the physical requirements for rubber surgeon's gloves, including dimensions, tensile strength, elongation, and watertightness. The specific numerical thresholds for these criteria are defined within ASTM D 3577-00, but are not listed in this 510(k) summary. The device's "performance" is simply its conformity to this standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in this document. Compliance with an ASTM standard would typically involve testing batches of gloves, but the number of gloves tested is not mentioned.
- Data Provenance: Not specified. This would involve product testing by the manufacturer (Cephas Medical Private Limited) which is located in India. The testing is likely prospective, as it's part of manufacturing quality control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a manufacturing standard compliance notification for a low-risk device, not a diagnostic device requiring expert interpretation for ground truth. Ground truth for gloves (e.g., integrity, strength) is established by objective physical tests per the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. Testing involves objective measurements against predefined limits in the ASTM standard, not subjective interpretation requiring adjudication.
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
- No. This is a surgeon's glove, not a diagnostic device or AI system. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance of these gloves (e.g., their physical integrity and strength) is established by objective physical measurements as defined by the ASTM D 3577-00 standard (e.g., tensile strength, elongation, freedom from holes).
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).