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Disposable surgical mask with clear window
Disposable surgical mask with clear window
The document describes a disposable surgical mask with a clear window, manufactured in Italy by Plus Biomedicals srl. It is a Class 1 medical device compliant with Directive 93/42/CEE and ISO 13485:2016 certified.
Specifications:
- Material Composition: Spunbond Polypropylene (30 g/m2 and 25 g/m2), Meltblown Polypropylene (25 g/m2), and Coex Transparent Polypropylene (60 g/m2).
- Dimensions: 95.5 x 175 mm, available in packs of 10.
- Elastic Band: Heat-sealable, 70% nylon, 30% elastomer, latex-free, with a diameter of 2.50mm and extension of 250%.
- Nose Clip: Twistband Fe/pp, food contact grade, 1x0.58mm.
Design and Usage:
The mask features a clear window strategically positioned to optimize mouth visibility. It requires adjustment using the folds and nose clip to fit different facial structures.
Certification and Compliance:
- ISO 13485:2016 certified for design, production, and marketing of surgical masks.
- First certification issued on 2020-10-16, valid until 2023-10-15, subject to annual audits and triennial reassessment.
Contact Information:
Plus Biomedicals Srl, Via L.Abbiati, 22A - 25134 Brescia, Email: [email protected], Tel: 030 0982904.
Catalog excerpts
Think Human, Think For Human DISPOSABLE SURGICAL MASK WITH CLEAR WINDOW
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DISPOSABLE SURGICAL MASK WITH CLEAR WINDOW MADE IN ITALY CLASS 1 MEDICAL DEVICE ACCORDING TO DIRECTIVE 93/42/CEE CERTIFIED COMPANY WITH ISO QUALITY SYSTEM 13485:2016 COMPOSITION SPUNBOND POLYPROPYLENE 25 g/m2 (TNT) MELTBLOWN POLYPROPYLENE 25 g/m2 (TNT) SPUNBOND POLYPROPYLENE 30 g/m2 (TNT) COEX TRANSPARENT POLYPROPYLENE 60 g/m2
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Product name: Disposable surgical mask with clear window I Producer: Plus Biomedicals srl I Dimensions: 95,5 x175 mm available in packs of 10 pz (Registration number as a medical device: 2103479 (see more on the website of the Ministry of Health: www.salute.gov.it) Origin: The product is 100% Made in Italy and follows all traceability regulations. How to use it: The clear window of the mask is designed in a strategic position to optimize the view of the mouth. Since the appearance of the face of each person is different, the position of the mask must be adjusted by acting on the folds present...
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SI CERTIFICA CHE IL SISTEMA DI GESTIONE PER LA QUALITA' DI WE HEREBY CERTIFY THAT THE QUALITY MANAGEMENT SYSTEM OPERATED BY PLUS BIOMEDICALS SRL VIA CAMILLO BROZZONI 9 - 25125 BRESCIA (BS) UNITA' OPERATIVE / OPERATIVE UNITS Vedere gli Allegati per le Unità Operative (n° 2 allegati) View the Annexes for the Operative Units (n° 2 annexes) E' CONFORME ALLA NORMA / IS IN COMPLIANCE WITH THE STANDARD ISO 13485:2016 PER LE SEGUENTI ATTIVITA' / FOR THE FOLLOWING ACTIVITIES Progettazione, produzione e immissione in commercio di mascherine chirurgiche Design, production and placing on the market of...
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Think Human, Think For Human Plus Biomedicals Srl Via L.Abbiati, 22A - 25134 Brescia [email protected] Tel: 030 0982904 P.IVA: 04056080981
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