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510(k) Data Aggregation
(249 days)
The powder free nitrile surgical glove, white color (Brand Name: Titanfine), is a sterile and single use device made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
Surgical glove is a disposable device worn on the surgical room personnel's hand or finger to prevent contamination during surgical procedures. The principle of operation is to provide a physical barrier between the surgical personnel's hands and the patient's open wound.
The powder free nitrile surgical gloves described in this submission are made of synthetic nitrile rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have white color and are single use.
The powder free nitrile surgical gloves described in this submission are tested for dimension, percent elongation, tensile, tensile at 500% elongation, free of pinholes, residue powder, water soluble proteins. The test results conform to related requirements in ASTM 3577-2009.
The powder free nitrile surgical gloves described in this submission are also tested biocompatibility per ISO 10993-10. The test results conform to related requirements in the standard.
The product sterilization is performed using radiation and the procedure is validated per ISO 11137-2: 2006.
This document is a 510(k) premarket notification for Powder Free Sterile Nitrile Surgical Gloves, White Color (Brand Name: Titanfine). It does not describe a study involving an AI device and human readers, but rather the substantial equivalence of a medical device (surgical gloves) to a predicate device. Therefore, many of the requested categories related to AI performance, human expert evaluation, and training/test sets are not applicable.
However, I can extract the acceptance criteria and demonstrated performance for the surgical gloves based on the provided text.
Here's a summary of the requested information, adapted for this medical device submission:
1. A table of acceptance criteria and the reported device performance
| Description | Acceptance Criteria (Predicate Device K122557) | Reported Device Performance (Subject Device K140989) |
|---|---|---|
| Dimension | ||
| Length | ≥265 mm | ≥265 mm |
| Width | within ±6 mm of specified value in ASTM 3577:2009 | within ±6 mm of the specified value in ASTM 3577:2009 |
| Palm, Finger, Cuff Thickness | ≥0.10 mm | ≥0.10 mm |
| Tensile Strength (MPa) | ≥17 | ≥17 |
| Tensile at 500% Elongation (MPa) | ≤ 7.0 | ≤ 7.0 |
| Percent Elongation | ≥650 | ≥650 |
| Free of Pinhole | Free of pinholes at AQL = 1.5 | Free of pinholes at AQL = 1.5 |
| Residue Powder | ≤ 2.0 mg | ≤ 2.0 mg |
| Water Soluble Protein | ≤ 200 µg/dm² | ≤ 200 µg/dm² |
| Primary Skin Irritation (ISO 10993-10: 2010) | Not a primary skin irritant | Not a primary skin irritant (Grade <1.0) under the conditions of study |
| Dermal Sensitization (ISO 10993-10: 2010) | Not a dermal sensitizer | Not a dermal sensitizer (Grade 0 or 1) under the conditions of study |
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 exact sample sizes for each test. It states: "The test results conform to related requirements in ASTM 3577-2009." and "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These standards typically define the sampling plans. The manufacturer is Hebei HongSen Plastics Technology Co., Ltd in Hebei Province, China, implying the testing likely occurred in China or by a contracted lab. The study is prospective in the sense that the device was manufactured and then tested to show compliance.
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 submission for sterile surgical gloves, not an AI diagnostic device requiring expert interpretation for ground truth. Compliance is determined by physical and chemical testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Compliance for surgical gloves is determined by objective measurement against pre-defined ASTM and ISO standards, not by human adjudication of interpretations.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the surgical gloves, the "ground truth" or reference standards are the consensus standards themselves, specifically:
- ASTM D3577-09 (Standard Specification for Rubber Surgical Gloves)
- ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D5712-10 (Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Isoprene Rubber Condoms)
- ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 11137-2: 2006 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose)
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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