(47 days)
A Powder Free Latex Surgical Glove is a disposable device intended in surgical settings for medical purpose that is worn on the hand to provide a barrier against potentially infectious materials and other contaminants.
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by the are and A surgeon's grove 15 a device intraction wound from contamination. (21CFR 878.4460)
Class I Surgeon's Glove (Powder Free) 79KGO that meets all the requirement of ASTM D3577.
Here's a breakdown of the acceptance criteria and study information for the BEIJING REAGENT LATEX PRODUCTS CO., LTD. "SNOW LOTUS" Powder Free Surgeon's Glove, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577-00 Requirement for Latex Surgical Gloves Powder Free) | Reported Device Performance (Value) | Meets Criteria |
|---|---|---|---|
| Length | |||
| Size 6.5 | Min. 265mm | Min. 265mm | Yes |
| Size 7 | Min. 265mm | Min. 270mm | Yes |
| Size 7.5 | Min. 265mm | Min. 270mm | Yes |
| Size 8 | Min. 265mm | Min. 270mm | Yes |
| Size 8.5 | Min. 265mm | Min. 280mm | Yes |
| Size 9 | Min. 265mm | Min. 280mm | Yes |
| Width | |||
| Size 6.5 | 83 ± 6 mm | 77-88 mm | Yes |
| Size 7 | 89 ± 6 mm | 84-94 mm | Yes |
| Size 7.5 | 95 ± 6 mm | 90-100 mm | Yes |
| Size 8 | 102 ± 6 mm | 96-108 mm | Yes |
| Size 8.5 | 108 ± 6 mm | 102-114 mm | Yes |
| Size 9 | 114 ± 6 mm | 108-120 mm | Yes |
| Thickness | |||
| Cuff | Min. 0.10 mm | 0.14mm | Yes |
| Palm | Min. 0.10 mm | 0.18mm | Yes |
| Finger | Min. 0.10 mm | 0.22mm | Yes |
| Physical Properties (Before Aging) | |||
| Tensile Strength | 24 MPa | 28 MPa | Yes |
| Elongation at break % | 750% | 830% | Yes |
| Modulus at 500% elongation | 5.5 MPa (max) | 3 MPa | Yes |
| Physical Properties (After Aging) | |||
| Tensile Strength | 18 MPa | 21 MPa | Yes |
| Elongation at break % | 560% | 800% | Yes |
| Modulus at 500% elongation | (Not specified by ASTM) | 3 MPa | N/A |
| Powder Content | 2 mg/glove max | 0.38 mg/glove | Yes |
| Protein Content | (Not explicitly stated in ASTM D3577 table, but mentioned in performance) | 31.4 ± 0.05 µg/g | N/A |
| Biocompatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible | Yes |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test set used for each parameter. It refers to "Inspection Level" and "AQL" (Acceptable Quality Limit) as per ASTM D3577 standards, implying that a statistically relevant sample size was drawn and tested according to these quality standards.
- Data Provenance: The tests were conducted by BEIJING REAGENT LATEX PRODUCTS CO., LTD., in P.R. CHINA. The data is retrospective, presented as a summary of compliance with recognized standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For physical and chemical tests of medical devices like gloves, "ground truth" is typically established through adherence to specified test methods and equipment calibration as defined by standards like ASTM D3577, rather than human expert consensus on interpretations.
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Adjudication method for the test set:
- This information is not applicable in the context of physical and chemical testing of medical devices. Adjudication methods like 2+1 or 3+1 are relevant for subjective assessments, typically in image-based diagnostic studies. For these gloves, adherence to quantitative measurements against established standards is the method of assessment.
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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, an MRMC study was not done. This type of study is specifically for evaluating AI in diagnostic contexts, usually involving human readers interpreting medical images. This document describes a physical medical device (surgical gloves), not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a physical medical device. There is no AI algorithm being evaluated for standalone performance.
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The type of ground truth used:
- The ground truth used is defined by internationally recognized consensus standards and requirements, specifically ASTM D3577-00 for most parameters, and FDA requirements for Biocompatibility and Pinholes. This represents a set of objectively measurable physical and chemical properties.
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The sample size for the training set:
- Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, this question does not apply.
§ 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).