X1 Box of 40 pcs BARRIER® (one size: L) Gown without hand towels SP PRIM PL (580100-00) Mölnlycke - Delynov
The X1 Carton de 40 pcs BARRIER® (taille unique : L) Casaque sans essuie mains SP PRIM PLMölnlycke is a medical device manufactured by Mölnlycke Health Care.
- Manufacturer: Mölnlycke Health Care.
- Reference: 580100-00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Mölnlycke BARRIER® SP PRIM PL surgical gown?
The BARRIER® SP PRIM PL surgical gown, referenced under code 580100-00, is a personal protective device designed by Mölnlycke Health Care. This product is presented as a gown without hand towels, offered in a single size L. Packaged in boxes of 40 pieces, this solution is specifically developed to meet protection needs during surgical interventions. It belongs to the BARRIER® range, recognized in the medical field for its expertise in protective barriers. This device is intended for use by healthcare professionals, particularly in sterile environments, to ensure effective separation between the practitioner and the operating field.
What are the clinical indications for this surgical gown?
This Mölnlycke gown is indicated for use during various surgical procedures, including oral surgery, implantology, and periodontology. Its use is recommended to maintain a controlled work environment and limit the risks of cross-contamination. As a protective garment, it is essential for dental surgeons and their assistants during implant placement or bone regeneration surgeries. Although specific MDR indications are not detailed in the sources, the BARRIER® SP PRIM PL product type is traditionally used to ensure the safety of healthcare personnel and the integrity of the sterile field during the operative act.
What are the technical characteristics of reference 580100-00?
The technical reference 580100-00 corresponds to a size L (Large) gown, delivered in a box format of 40 units for optimized stock management in dental offices or clinics. This SP PRIM PL model is distinguished by the absence of hand towels included in the individual packaging, allowing for targeted use by practitioners who already have their own drying protocols. The design by Mölnlycke prioritizes ergonomics and comfort during surgical effort. Exact technical specifications of the material are not provided, but the BARRIER® range is developed to offer adequate fluid resistance while guaranteeing the freedom of movement essential during precision gestures in oral surgery.
What are the contraindications for the use of this device?
There are no specific clinical contraindications listed for this gown, apart from strict compliance with aseptic protocols. However, as with any protective medical device, the integrity of the packaging should be checked before use; damaged packaging compromises the sterility of the product. Use must be reserved for qualified personnel trained in surgical gowning techniques. In the event of a skin reaction or hypersensitivity upon contact with the material, it is recommended to discontinue use and consult the technical instructions from the manufacturer Mölnlycke Health Care to verify the compatibility of the components with the user.
What are the precautions for use and storage for this box of 40 pieces?
To guarantee the effectiveness of the protection offered by BARRIER® gowns, it is imperative to store the box of 40 pieces in a dry place, away from direct light and humidity. Each gown is for single use only; it must under no circumstances be re-sterilized or reused, at the risk of losing its protective properties and increasing the infectious risk for the patient. Practitioners must follow conventional gowning steps to avoid contaminating the outside of the gown during placement. After the intervention, the device must be disposed of according to current protocols for clinical waste (ASRI).
Who is the manufacturer and what standards are met by this product?
The official manufacturer of this device is Mölnlycke Health Care, a global leader in the manufacture of surgical and wound care solutions. Although specific data regarding CE marking or the precise regulatory class are not mentioned in the current source documentation, Mölnlycke brand products are recognized for their compliance with international quality requirements. For precise details on certifications, applied ISO standards, or exact regulatory status (MDR), healthcare professionals are invited to systematically refer to the product labeling and the declaration of conformity provided by the manufacturer.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.