Description
Product Details
Sizing: XS, S, M, L, XL
100% Nitrile Disposable Textured Finger Tip
Ambidextrous
Powder Free
Non – Sterile Colour: Blue
100 gloves per box
Product Information
Comfortable, super so, flexible and as an alternate to Latex provides an option for those who have Type I allergic reactions associated with rubber.
Provides a full range of movement with excellent flexibility, providing long-term comfort to reduce stress & fatigue. Feel & fits like Latex.
Suitable for use in Hospitals, Clinics, Laboratories, Workshops, Food Processing & Preparation, Beauty Industries, Healthcare, Nursing, Aged care, I.T. industries and around the home.
When good protection against microbes is required.
100% Latex Free.
Feels like natural rubber.
Tackle Sensitivity and Stretch Performance.
Textured Finger Tip.
When sharp objects are handled (Limited protection).
Handling of chemicals and some cytostatics (Chemo)(limited and occasional protection).\ Radiology. Waterproof (Hot & Cold minimal pressure).Food Safe
(Suitable for some faty foods & oils)
APPLICATIONS:
• To protect the patent and the professional.
• To prevent spreading of infections and microbes via the
hands.
• To protect the hands from
o Needle sick injuries
o Chemicals & cleaning products
o Occupatonal accidents
-sterile.
GLOVE USE
• Medical gloves are always single-use.
• Gloves can be either sterile or non
• Disposable gloves can not be cleaned.
• Single-use is either by patent or medical professional.
Qualifications
| Name | Testing Criteria |
| FDA | Owner / Operator – 10073578 Listng D401324 510(k) No: K131823 Product Code: LZC & LZA |
| ASTM | ASTM D6319-2019 ASTM D6978-5:2019 ASTM D573 |
| TGA | ARTG 352707 |
| CE | Marking according to Class I Annex VII of the 93/42/EEC medical Device Directve |
| TUV | ISO 9001:2015 EN ISO 13485:2016 |
| SATRA | Annex II PPE Regulaton (EU) 2016/425 Cat III product. EN ISO 374-1:2016 + A:2018/Type C EN ISO 374-4:2013 EN ISO 374-5:2016 |
| SGS | BS EN 455-1:2000 Part 1 BS EN 455-2:2015 Part 2 BS EN 455-3:2015 Part 3 |
Download the certificates and information. Click Here
Technical Data
TGA Registration
Inclusion on the TGA Australian Register of Therapeutic Goods (ARTG) – from January 2021
Medical device products are regulated by the TGA under the Therapeutic Goods Act 1989. Before supply in Australia, these goods need to be included on the ARTG.
To meet the requirements for inclusion on the Register, TCG must meet requirements for product quality, safety and performance in accordance with Australian or international standard requirements. This pre-market data is provided for assessment, and market authorization is then granted to allow entry of the therapeutic goods to the ARTG.
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