1 carton of 4 boxes of 50 pairs (200 pairs) of Biogel® PI Micro Gloves - Size 6.0 to 9.0® - Delynov for implantology, oral surgery, dental surgery, dentist, bone grafting, and maxillofacial surgery.

What is the Biogel PI Micro glove from the Marque?

The Biogel PI Micro from the Marque is a high-performance synthetic surgical glove, designed without natural rubber latex to eliminate associated allergic risks. This device stands out for its exceptional thinness, being 20% thinner than the standard Biogel PI gloves in the range. Its polyisoprene structure offers comfort and fit comparable to a second skin, mimicking the properties of latex without its drawbacks. Packaged in cartons of 200 pairs (4 boxes of 50), it is specifically developed for demanding environments where dexterity is paramount. This glove is sterile, powder-free, and has been tested for use with chemotherapy agents according to the ASTM D6978 standard, guaranteeing versatile protection for healthcare professionals.

What are the clinical indications for this device?

These latex-free surgical gloves are indicated for a wide variety of specialized interventions. In dental and oral surgery, they are particularly suited for implantology and bone grafting procedures where the perception of tissues and bone structures is critical. Maxillofacial surgery practitioners also benefit from their thinness for micro-dissections or complex sutures. The intended use by the manufacturer Molnlycke Health Care AB targets situations requiring superior tactile sensitivity, whether the glove is worn alone or in a double-gloving system. Their synthetic design makes them a preferred choice for protecting both the patient and the dental surgeon against Type I latex allergic reactions, while maintaining a high level of sterile barrier.

What are the technical characteristics of these gloves?

The technical characteristics of the Biogel PI Micro are based on engineering aimed at tactile excellence. In addition to its 20% thickness reduction compared to PI standards, it features an AQL (Acceptable Quality Level) of 0.65 for the absence of perforations, determined after the packaging stage. This rigorous threshold ensures high structural integrity. The device integrates a clear and fast perforation indication system, facilitating the immediate detection of a breach during the operative act. Furthermore, its low endotoxin level, below 20 EU per pair, is a crucial technical parameter for minimizing inflammatory risks or postoperative complications. This polyisoprene surgery glove is certified both as a medical device and as personal protective equipment (PPE).

What are the contraindications for use?

According to information from the manufacturer Molnlycke Health Care AB, the Biogel PI Micro is a synthetic glove without natural rubber latex, which constitutes a direct response to contraindications related to latex allergies. There are no specific contraindications mentioned outside of the usual precautions for use for sterile devices. It is imperative to refer to the instructions for use accompanying the products for detailed information. Although tested for chemotherapy, the user must verify specific compatibility with the chemical agents used. As with any invasive or protective device, the integrity of the glove must be checked before use, and the perforation indication system must be monitored throughout the intervention to ensure aseptic safety.

What are the precautions for use and safety?

To ensure maximum safety, Biogel PI Micro gloves from the Marque must be used in accordance with surgical asepsis protocols. Although they offer comfort close to latex, their synthetic nature requires a precise fit to avoid excessive tension. In the case of high-risk procedures, the manufacturer recommends double-gloving, for example by combining this model with a Biogel PI Micro Underglove. This configuration allows for full advantage of the colored alert system in case of perforation of the outer layer. Being powder-free, they limit the risk of starch-related granulomas. It is advised to store the boxes in a dry place away from direct light to preserve the mechanical properties of the polyisoprene until their use in the operating block.

Who is the manufacturer and what standards are respected?

The official manufacturer of this device is Molnlycke Health Care AB. Biogel PI Micro gloves comply with strict European regulatory requirements, classified as a Class IIa device and bearing the CE2797 marking. They also meet certification standards for personal protective equipment (PPE), guaranteeing a high level of safety for healthcare personnel. Manufacturing quality is attested by studies showing that Biogel gloves have one of the lowest failure rates on the market. By respecting the ASTM D6978 standard for resistance to chemotherapy agents and maintaining very low endotoxin levels, the Marque ensures a reliable product for the most demanding surgeons in implantology and dental surgery.

State of the art

Single-use sterile surgical kits significantly reduce intraoperative contamination.