Wide Range of Latex Surgical, Gynaecological and Examination Gloves - www.medismartglove.com - Sterile Latex Surgical Glove
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Wide Range of Latex Surgical, Gynaecological and Examination Gloves www.medismartglove.com IS: 13422 IS: 13422 9001:2015 14001-2015 13485:2016 CML: 6400090705 CML: 4661670 2460 510 (K)
DIVERSITY IN PRODUCTS BORN IN NATURE MODIFIED IN OUR HANDS CONSISTENCY IN QUALITY ABOUT US St. Marys Rubbers Pvt. Ltd. is the largest and reputed manufacturer and Exporter of Latex Surgical & Gynaecological Gloves. We have our own latex as the raw material and have a produc on capacity of 0.6 million pairs of surgical gloves per day. Products are manufactured, packed in asep c conditions equipped with most modern machinery like fully automated dipping line, auto robot stripping, automa c pinhole tes ng machines, automated walle ng, prin ng, pouching, sealing machines & in-house chemical & microbiology lab and steriliza on unit. We strive to achieve the highest levels of customer sa sfac on by providing products of Superior Quality while adhering to the delivery melines. Established in 2002 under the Companies Act of 1956. St. Marys Rubbers Pvt. Ltd. currently exports to over 40 countries worldwide in the regions of America, Europe, Middle East, Africa etc... As an own-brand manufacturer, we have developed a range of successful brands such as Medismart, Medismart Plus and Soteria which are trusted and recognized by laboratories, hospitals and surgeons around the world. VISION To become a trusted manufacturer and supplier of a broad range of medical gloves with superior safety and protec on reliability. QUALITY POLICY MISSION We are Commi ed to delight our customers by: Our goal is to respond to the ever-changing needs of the Consistently mee ng or exceeding customer’s expecta on healthcare industry that demands protec ve products for product quality and performance. that are safer to use and produced with efficient and Timely delivery of products and sevices to meet customer’s requirments. environmentally responsible processes. Con nual improvement of processes and systems. Complying with all statutory/regulatory requirments
OUR EXCLUSIVE RANGE Sterile Latex Surgical Gloves Powdered IS: 13422 Medismart Premium 2460 9001:2015 13485:2016 14001-2015 CML: 4661670 510 (K) Medismart Medistar Soteria Sterile Latex Surgical Gloves Powder Free (Polymer Coated) AFE IGHT ELIABLE Medismart Premium Plus Medismart Plus Sterile Latex Gynaecological Gloves Powder Free (Polymer Coated) Medismart Plus Sterile Latex Orthopaedic Gloves Powder Free Medismart Plus Non - Sterile Examina on Gloves Medismart - Latex Examina on Gloves Powdered Medismart Plus - Latex / Nitrile Examina on Gloves Powder Free
STERILE LATEX SURGICAL PHYSICAL PROPERTIES GLOVES Before Ageing A er Ageing PRE POWDERED Characteris cs ASTM D 3577 SMR ASTM D 3577 SMR Tensile Strength (Mpa) 24 Min 27 Min 18 Min 20 Min PRODUCT DESCRIPTION Elonga on % 750 Min 900 Min 560 Min 700 Min Stress at 500% Elonga on (Mpa) 5.5 Max 3.5 Max N/A N/A Gloves compounded primarily from natural rubber latex (Type-1). Force at break (N) EN 455-2 SMR EN 455-2 SMR Creamy white to pale yellow in colour. 9.0 Min 16 Min 9.0 Min 12 Min Free from dirt marks, oil stains, embedded foreign par cles, coagulum etc. Sterile, anatomically shaped medical gloves with the thumb posi oned towards the PACKING SPECIFICATIONS palmar surface of the index finger rather than laying flat. Powder content less than 15 mg/dm2 Packing No. of Pairs The cuff shall fit closely without being construc ve and it shall not roll back or ruckle Pouch 1 Pair while in use. Dispenser Box 50 Pairs Anatomically shaped with micro rough surface in palm and finger area. Carton Box 500 pairs (10 Dispensers) Using absorbable Corn Starch USP grade. Sterilized by ETO / Gamma steriliza on as per customer requirements. Container Loadability 20 Ft GP : 200000 Pairs 40 Ft HQ: 460000 Pairs Protein content will be less than 200 µg/dm 2 Hypoallergenic reducing poten al allergic reac ons. GLOVES SIZES Passes viral penetra on test 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 Each glove has non-detectable levels of chemical residue Marking and labelling as per regulatory and customer requirements. The Sterility Assurance Level (SAL) is 10 -6 Biologically compa ble as per ISO 10993-Part 5 & 10 Size of the gloves is embossed on the palm area. Manufactured in a clean environment to achieve low bioburden level prior to sterilisa on QUALITY STANDARDS Manufactured under EN ISO 13485:2016, ISO 14001:2015 and ISO 9001:2015 Quality Management System. Conforms to EN 455’ASTM D3577,ISO 10282 & IS 13422 Standards. Factory Standard of AQL 0.65 for pinholes CE mark -MDD Class IIa 100 % inspected using air pumps
PHYSICAL PROPERTIES STERILE LATEX SURGICAL GLOVES Characteris cs Before Ageing ASTM D 3577 SMR A er Ageing ASTM D 3577 SMR PRE-POWDERED Tensile Strength (Mpa) 24 Min 26 Min 18 Min 19 Min Elonga on % 750 Min 850 Min 560 Min 650 Min PRODUCT DESCRIPTION Stress at 500% Elonga on (Mpa) 5.5 Max 2.3 Max N/A N/A Gloves compounded primarily from natural rubber latex (Type-1 ). Force at break (N) EN 455-2 SMR EN 455-2 SMR 9.0 Min 13 Min 9.0 Min 11 Min Creamy white to pale yellow in colour. Free from dirt marks, oil stains. embedded foreign par cles, coagulum etc. Sterile, anatomically shaped medical gloves with the thumb posi oned towards the PACKING SPECIFICATIONS palmar surface of the index finger rather than laying flat. Packing No. of Pairs Sterile gloves for single use only. Pouch 1 Pair The cuff shall fit closely without being construc ve and it shall not roll back or ruckle while in use. Dispenser Box 50 Pairs Anatomically shaped with micro rough surface in palm and finger area. Carton Box 500 pairs (10 Dispensers) Using absorbable corn starch USP grade. Container Loadability 20 Ft GP : 200000 Pairs The Sterility Assurance Level (SAL) is 10 -6 40 Ft HQ : 460000 Pairs Biologically compa ble as per ISO 10993-Part 5 & 10 Size of the gloves is embossed on the palm area. GLOVES SIZES Manufactured in a clean environment to achieve low bioburden level prior to 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 sterilisa on Marking and labelling as per regulatory and customer requirements. Sterilized by ETO / Gamma steriliza on as per customer requirements. Passes viral penetra on as per ASTM F 1671 Passes Bacterial Endotoxin test as per USP 41 Powder content less than 15 mg/dm2 2 Protein content less than 200 µg/dm QUALITY STANDARDS Manufactured under EN ISO 13485:2016, ISO 14001:2015 and ISO 9001:2015 Quality Management System. Conforms to ASTM D 3577,EN455, IS0 10282 and IS 13422 Standards CE mark- MDD Class lla 100 % inspected by air pumps Factory Standard of AQL 1.5 for pinholes
PHYSICAL PROPERTIES Before Ageing A er Ageing Characteris cs ASTM D 3577 SMR ASTM D 3577 SMR Tensile Strength (Mpa) 24 Min 25 Min 18 Min 19 Min STERILE LATEX SURGICAL GLOVES Elonga on % 750 Min 850 Min 560 Min 650 Min Stress at 500% Elonga on (Mpa) N/A PRE-POWDERED Force at break (N) 5.5 Max EN 455-2 2 Max SMR N/A EN 455-2 SMR 9.0 Min 12 Min 9.0 Min 11 Min PACKING SPECIFICATIONS PRODUCT DESCRIPTION Packing No. of Pairs Creamy white in color. Pouch 1 Pair Manufactured from compounded natural rubber latex (Type- 1 ) Free from dirt marks.oil stains.embedded foreign par cles,coagulum etc. Dispenser Box 50 Pairs Anatomically shaped with micro rough surface in palm and finger area. Carton Box 500 pairs (10 Dispensers) The cuff shall fit closely without being construc ve and It shall not roll bock or ruckle while In use. Container Loadability 20 Ft GP : 250000 Pairs 40 Ft HQ : 590000 Pairs Sterile anatomically shaped medical gloves with the thumb posi oned toward the palmar surface of the index finger rather than laying flat. GLOVES SIZES Sterilized by Ethylene oxide 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 Bioburden and sterility complies as per regulatory requirements. Marking and labelling as per regulatory and customer requirements. Hypoallergenic reducing poten al allergic reac ons QUALITY STANDARDS Manufactured under EN ISO 13485:2016,ISO 14001:2015 and ISO 9001:2015 Quality Management System Conforms to IS:13422 standard
STERILE LATEX PHYSICAL PROPERTIES SURGICAL GLOVES Characteris cs Before Ageing A er Ageing ASTM D 3577 SMR ASTM D 3577 SMR POWDER FREE Tensile Strength (Mpa) 24 Min 26 Min 18 Min 19 Min Elonga on % 750 Min 850 Min 560 Min 650 Min Stress at 500% Elonga on (Mpa) 5.5 Max 2.5 Max N/A N/A PRODUCT DESCRIPTION Force at break (N) EN 455-2 SMR EN 455-2 SMR 9.0 Min 14 Min 9.0 Min 11 Min Gloves compounded primarily from natural rubber latex (Type-1). Free from dirt marks, oil stains, embedded foreign par cles, coagulum etc. PACKING SPECIFICATIONS Sterile, anatomically shaped medical gloves with the thumb posi oned towards the Packing No. of Pairs palmar surface of the index finger rather than laying flat. Sterilized by ETO. Pouch 1 Pair Anatomically shaped with micro rough surface in palm and finger area. Dispenser Box 50 Pairs Powder Free Surgical gloves are coated with a unique blend of polymer to provide Carton Box 500 pairs (10 Dispensers) excellent dry and damp hand donning capabili es Powder content less than 2 mg/glove Container Loadability 20 Ft GP : 250000 Pairs 40 Ft HQ : 590000 Pairs The Sterility Assurance Level (SAL) is 10 -6 Manufactured in a clean environment to achieve low bioburden level prior to sterilisa on GLOVES SIZES 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 Marking and labelling as per regulatory and customer requirements. QUALITY STANDARDS Manufactured under EN ISO 13485:2016, ISO 14001:2015 and ISO 9001:2015 Quality Management System. Conforms to ASTM D 3577,EN455 ,IS 13422 and ISO 10282 Standards. Factory Standard of AQL 1.5 for pinholes
PHYSICAL PROPERTIES Before Ageing A er Ageing Characteris cs ASTM D 3577 SMR ASTM D 3577 SMR STERILE LATEX Tensile Strength (Mpa) 24 Min 28 Min 18 Min 20 Min SURGICAL GLOVES PREMIUM Elonga on % Stress at 500% Elonga on (Mpa) 750 Min 5.5 Max 900 Min 3.5 Max 560 Min N/A 800 Min N/A POWDER FREE (POLYMER COATED) Force at break (N) EN 455-2 SMR EN 455-2 SMR 9.0 Min 16 Min 9.0 Min 12 Min PRODUCT DESCRIPTION PACKING SPECIFICATIONS Gloves compounded primarily from natural rubber latex (Type·l). Creamy white to pale yellow in colour. Packing No. of Pairs Free from dirt marks, oil stains, embedded foreign par cles, coagulum etc Pouch 1 Pair Sterile, anatomically shaped medical gloves with the thumb posi oned towards the Dispenser Box 50 Pairs palmar surface of the index finger rather than laying flat. Sterile gloves for single use only. Sterile un l package is opened or damaged. Carton Box 500 pairs (10 Dispensers) Anatomically shaped with micro rough surface in palm and finger area. Container Loadability 20 Ft GP : 200000 Pairs Powder Free Surgical gloves are coated with a unique blend of polymer to provide 40 Ft HQ: 460000 Pairs excellent dry and damp hand donning capabili es GLOVES SIZES Latex protein content not more than 50µg/ dm 2 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 Powder content less than 2 mg/glove Marking and labelling as per regulatory and The Sterility Assurance Level (SAL) is 10-6 customer requirements. Biologically compa ble as per ISO 10993-Part 5 & 10 Size of the gloves is embossed on the palm area. Manufactured in a clean environment to achieve low bioburden level prior to sterilisa on Sterilized by ETO / Gamma steriliza on as per customer requirements. QUALITY STANDARDS Manufactured under EN ISO 13485:2016, ISO 14001:2015 and ISO 9001:2015 Quality Management System. Conforms to ASTM D 3577,EN455 ,IS 13422 and ISO 10282 Standards. Factory Standard of AQL 0.65 for pinholes Registered with US FDA 510 k CE mark- MDD Class IIa 100 % inspected using air pumps
PHYSICAL PROPERTIES Before Ageing A er Ageing STERILE LATEX SURGICAL GLOVES Characteris cs ASTM D 3577 SMR ASTM D 3577 SMR POWDER FREE (POLYMER COATED) Tensile Strength (Mpa) Elonga on % 24 Min 750 Min 26 Min 850 Min 18 Min 560 Min 19 Min 650 Min Stress at 500% Elonga on (Mpa) 5.5 Max 2.5 Max N/A N/A PRODUCT DESCRIPTION Force at break (N) EN 455-2 SMR EN 455-2 SMR 9.0 Min 14 Min 9.0 Min 11 Min Gloves compounded primarily from natural rubber latex (Type-1). Free from dirt marks, oil stains, embedded foreign par cles, coagulum etc. PACKING SPECIFICATIONS Sterile, anatomically shaped medical gloves with the thumb posi oned towards the Packing No. of Pairs palmar surface of the index finger rather than laying flat. Anatomically shaped with micro rough surface in palm and finger area. Pouch 1 Pair Powder Free Surgical gloves are coated with a unique blend of polymer to provide Dispenser Box 50 Pairs excellent dry and damp hand donning capabili es Carton Box 500 pairs (10 Dispensers) Latex protein content not more than 50µg/ dm2 Powder content less than 2 mg/glove Container Loadability 20 Ft GP : 200000 Pairs The Sterility Assurance Level (SAL) is 10 -6 40 Ft HQ : 460000 Pairs Biologically compa ble as per ISO 10993-Part 5 & 10 GLOVES SIZES Manufactured in a clean environment to achieve low bioburden level prior to sterilisa on 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 Sterilized by ETO / Gamma steriliza on as per customer requirements. Marking and labelling as per regulatory and Passes viral penetra on as per ASTM F 1671 customer requirements. Passes Bacterial Endotoxin test as per USP 41 QUALITY STANDARDS Manufactured under EN ISO 13485:2016, ISO 14001:2015 and ISO 9001:2015 Quality Management System. Conforms to ASTM D 3577,EN455 ,IS 13422 and ISO 10282 Standards. Factory Standard of AQL 1.5 for pinholes Registered with US FDA 510 k CE mark- MDD Class IIa 100 % inspected using air pumps
PHYSICAL PROPERTIES GYNAECOLOGY Before Ageing A er Ageing Characteris cs ASTM D 3577 SMR ASTM D 3577 SMR STERILE LATEX Tensile Strength (Mpa) 24 Min 28 Min 18 Min 20 Min GYNAECOLOGICAL Elonga on % Stress at 500% Elonga on (Mpa) 750 Min 5.5 Max 900 Min 2.5 Max 560 Min N/A 800 Min N/A GLOVES DISPOSABLE Force at break (N) EN 455-2 9.0 Min SMR 14 Min EN 455-2 9.0 Min SMR 12 Min LONG CUFF | POWDER FREE | MICRO ROUGH SURFACE PACKING SPECIFICATIONS Packing No. of Pairs PRODUCT DESCRIPTION Pouch 1 Pair Extra long cuff covers the obstetricians gown sleeves and protects the user’s Dispenser Box 25 Pairs forearm against fluid contamina on Carton Box 200 pairs (8 Dispensers) For manual removal of placenta and for surgery of cervix, the extra length of cuff is of great advantage GLOVES SIZES The micro rough texture of glove surface helps in firm grip of the newborn 6.5 | 7.5 | 8.5 baby and gives good grip of surgical instruments during episiotomy Marking and labelling as per regulatory and Protects sensi ve ssues against contact with abrasive materials customer requirements. Extra length protects against AIDS/HIV infec ons Hypoallergenic reducing poten al allergic reac ons. Sterilized by validated procedure as per ISO 11135:2014 which maintains the EO residue below 4mg/unit and sterility assurance level is 10-6 Passes Viral Penetra on test as per ASTM F 1671 Biologically compa ble as per ISO 10993-Part 5 & 10 Passes Bacterial Endotoxin test as per USP 41 Manufactured in clean environment to reduce bioburden level prior to steriliza on. QUALITY STANDARDS Manufactured under EN ISO 13485:2016 Quality Management System. Conforms to ASTM D 3577,EN455 and ISO 10282 & IS 13422 Standards. Factory Standard of AQL 0. 65 for pinholes 100 % inspected by air pumps
PHYSICAL PROPERTIES Before Ageing A er Ageing STERILE LATEX ORTHOPAEDIC GLOVES Characteris cs ASTM D 3577 SMR ASTM D 3577 SMR POWDER FREE (POLYMER COATED) Tensile Strength (Mpa) 24 Min 26 Min 18 Min 19 Min Elonga on % 750 Min 850 Min 560 Min 650 Min Stress at 500% Elonga on (Mpa) 5.5 Max 2.5 Max N/A N/A PRODUCT DESCRIPTION Force at break (N) EN 455-2 SMR EN 455-2 SMR 9.0 Min 14 Min 9.0 Min 11 Min Gloves compounded primarily from natural rubber latex (Type-1) The polymer coa ng is resistant to disinfectants and adds another layer between PACKING SPECIFICATIONS the skin and the latex. Packing No. of Pairs Free from dirt marks, oil stains, embedded foreign par cles, coagulum etc. The ultra thickness of medismart plus Orthopaedic makes this glove 40% more resistant Pouch 1 Pair than standard powder free surgical gloves Dispenser Box 50 Pairs Ergonomically designed for be er comfort Carton Box 500 pairs (10 Dispensers) Micro rough external surface for outstanding grip and preven ng instruments from slipping in wet and dry environments. Container Loadability 20 Ft GP : 200000 Pairs 40 Ft HQ : 460000 Pairs Specific latex formula on with reduced use of chemical acceletators for minimising the risk of skin irrita on. GLOVES SIZES Low protein content 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 Marking and labelling as per regulatory and customer requirements. QUALITY STANDARDS Manufactured under EN ISO 13485:2016, ISO 14001:2015 and ISO 9001:2015 Quality Management System. Conforms to ASTM D 3577,EN455 ,IS 13422 and ISO 10282 Standards. Sterilized by ETO. Bio-burden and sterility complies as per regulatory requirements. Hypoallergenic reducing poten al allergic reac ons. Factory Standard of AQL 0.65 for pinholes Shelf life 3 years
LATEX EXAMINATION GLOVES (POWDER FREE) PACKING SPECIFICATIONS PRODUCT DESCRIPTION Creamy white in colour. Packing Quan ty Gloves compounded primarily from natural rubber latex (Type-1). Free from dirt marks, oil stains, embedded foreign par cles, coagulum etc. Dispenser Box 100 Pieces Ambidextrous with smooth surface fit either hand and textured in finger ps The cuff shall fit closely without being construc ve and it shall not roll back or ruckle Carton Box 2000 Pieces while in use. Latex protein content not more than 50µg/ dm2 Powder content less than 2mg/glove. Powder Free Examina on gloves are coated with a unique blend of polymer to GLOVES SIZES Provide excellent dry and damp hand donning capabili es. Ex-Small, Small, Medium, Large, Ex-Large Marking and labelling as per regulatory and customer requirements. LATEX EXAMINATION GLOVES (PRE POWDERED) PRODUCT DESCRIPTION Gloves compounded primarily from natural rubber latex (Type- 1) Creamy white in colour. Free from dirt marks, oil stains, embedded foreign par cles, coagulum etc Ambidextrous with smooth surface fit either hand and textured in the finger area. The cuff shall fit closely without being construc ve and it shall not roll back or ruckle while in use. Using absorbable Corn Starch USP grade. Ambidextrous fit either hand. QUALITY STANDARDS Conforms to ASTM D3578 and EN455 Standards. Manufactured under EN ISO 13485:2016,ISO 14001:2015 and ISO 9001:2015 Quality Quality Management System.
NITRILE EXAMINATION GLOVES POWDER FREE PRODUCT DESCRIPTION Made from 100 % Nitrile synthe c rubber (NBR) protein free PACKING SPECIFICATIONS Ambidextrous and Non sterile Free from dirt marks,oil stain,embedded foreign par cles,coagulum etc Packing Quan ty QUALITY STANDARDS Dispenser Box 100 Pieces ASTM D 6319-10 Standard specifica on for Nitrile Examina on Gloves Carton Box 2000 Pieces GLOVES SIZES Small, Medium, Large, Ex-Large Marking and labelling as per regulatory and customer requirements.
USFDA CE ISO OUR STRENGTHS LARGEST PRODUCTION CAPACITY: 600,000 PAIRS OF SURGICAL GLOVES PER DAY OWN LATEX AS THE RAW MATERIAL FROM OUR OWN LATEX CENTRIFUGING PLANT WHICH IS THE LARGEST IN INDIA EXPORTING TO MORE THAN 40 COUNTRIES WORLDWIDE FULLY AUTOMATED DIPPING LINE WITH ONLINE POLYMER COATING FOR POWDER FREE GLOVES ROBOTIC STRIPPING FACILITY IN THE PRODUCTION AUTOMATED PINHOLE TESTING FACILITY IN-HOUSE FACILITIES FOR PRINTING, PACKING, & STERILIZATION
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IS: 13422 IS: 13422 9001:2015 14001-2015 13485:2016 CML: 6400090705 CML: 4661670 2460 TO REACH US: ST. MARY'S RUBBERS PVT. LTD SMR NATURALS PVT LTD subin@stmarysrubbers.com Koovappally P.O., Kanjirappally, XVII/401B Thottamkavala, +91 9447 486 270 Kottayam(Dist), Kerala, Vizhikkathodu P.O Kanjirappally, arun@stmarysrubbers.com India - 686518 Kottayam, Kerala, India - 686518 +91 9447 556 270 Email: marketing@stmarysrubbers.com Email: sales@smrnaturals.in Website: medismartglove.com Ph: +91 (0) 4828 251533 Ph: +91 9447 486 270, +91 9447 563 270, 91 (0) 4828 252 277, 252 287
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