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510(k) Data Aggregation
(34 days)
The Biogel® OrthoPro® Brown Surgical Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The proposed device, the Biogel® OrthoPro® Brown Surgical Glove is manufactured of natural rubber latex colored with brown nigmentation. The Biogel® OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years with the addition of the brown colorant. The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Brown Surgical Glove to provide the user with this additional feature: Slightly Curved Former with Independent/Displaced thumb.
The document describes the Biogel® OrthoPro® Brown Surgical Glove.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (requirements from ASTM D3577, 21 CFR 800.20, and ASTM D5712) | Reported Device Performance (Result) |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated (implied non-irritating) | Gloves are non-irritating. |
| ISO Closed Patch Sensitization | Not explicitly stated (implied no sensitization potential) | Gloves do not display any potential for sensitization. |
| Dimensions | Requirements of ASTM D3577 | Gloves meet requirements of ASTM D3577. |
| Physical Properties | Requirements for rubber surgical gloves per ASTM D3577 | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Requirements of 21 CFR 800.20 and ASTM D3577 | Gloves exceed the requirements of 21 CFR 800.20 and ASTM D3577. |
| Protein Extractables | Requirements of ASTM D5712 | Gloves meet requirements of ASTM D5712. |
| Powder Residual | Powder level requirements for "Powder-Free" designation per ASTM D3577 (using ASTM standard D6142, presumably < 2mg/glove) | Results generated values below 2mg of residual powder per glove. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the performance tests (Primary Skin Irritation, Sensitization, Dimensions, Physical Properties, Freedom from Holes, Protein Extractables, Powder Residual). It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
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. The ground truth for this medical device (surgical gloves) is established through standardized performance testing against recognized ASTM and CFR standards, not through expert consensus in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As noted above, the ground truth is established through standardized testing, not expert 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:
Not applicable. This is not an AI-assisted diagnostic device; it is a surgical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is based on established, objective, and quantitative performance standards outlined in:
- ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
- 21 CFR 800.20 (Listing and Labeling of Articles for Sanitary Purposes - pertaining to freedom from holes for gloves)
- ASTM D5712 (Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Latex Products Using the Modified Lowry Method)
- ASTM D6142 (Standard Test Method for Residual Powder on Medical Gloves)
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set. The device is evaluated through direct performance testing against established standards.
9. How the ground truth for the training set was established:
Not applicable, as no training set is relevant for this device.
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