(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 |
§ 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).