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Toll Free
Number 1800-102-5025 |
FAQ's
Yes, Absorbable &
Non absorbable sutures. In Absorbable sutures, the company manufactures
Catgut, Polyglycolic Acid (PGA), Polyglycolic Acid (Fast) the rapidly
absorbing variety, Poliglecaprone 25, Polydioxanone and Polyglactin 910
sutures. In Non absorbable sutures, the Company manufactures Silk, Nylon
(Polyamide), Polypropylene, Polyester & Stainless steel sutures. In
Nonabsorbable sutures, the company manufactures Silk, Nylon (Polyamide),
Polypropylene, Polyester & Stainless steel sutures.
Yes, the company
can manufacture any suture-needle combination. The catalogs contain only
those set of codes which are normally sold in the Indian market. However,
all the above sutures ranging from size 5 to size 10-0 & needle of
length from 6mm to 90mm are manufactured by us.
No. Only
Polyglycolic Acid (PGA), Silk, Nylon & Polypropylene & Polyester
sutures are CE & USFDA certified.
All colours used
in suture manufactured are USFDA approved & listed below:
- Catgut: Pyrogallol
- Polyglycolic Acid: D & C VIOLET No.2
- Poliglecaprone 25: D & C VIOLET No.2
- Polydioxanone: D&C VIOLET No.2
- Polyglactin 910: D&C VIOLET No.2
- Silk: Haematin HCK (Logwood Extract)
- Nylon: Haematin HCK (Logwood Extract)
- Polypropylene: Pigment Blue or Phthalocyanine Copper
- Polyester: D & C Green No.5
For all our
sutures range of products, we have done the bio compatibility studies
(primary skin irritation study in rabbits and maximization and sensitization
study in guinea pigs) as per I.S.O. 10993-10 guidelines and in-vitro cyto
toxicity study as per I.S.O. 10993-5 guidelines. In addition to the above
studies, we also have done the absorption studies for the absorbable
sutures. Abstract of the study reports are available on request.
Yes, In addition
to product certifications, the plant is ISO 9001/2000, ISO 13485 /2003 &
WHO GMP certified.
All certificates
are hosted on the company's website as Pdf files. These certificates can
either be downloaded or printed.
All products
manufactured by the Company like Sutures, Meshes, Staplers, Bonewax,
Umbilical cotton tapes, Ligaclip, Synthetic cast etc. can be manufactured in
OEM brands.
Yes, suture
materials are available for sale to suture manufacturers in bulk. They have
the same grade of quality. The drilled end needles are also available to
suture manufacturers both in AISI 420 & AISI 302 grade of stainless
steel for sale.
utures are
sterilized by EO (in house) except Polyglycolic acid - fast absorbing
suture. Meshes are also sterilized by EO. Polyglycolic acid sutures (Fast
absorbing), Bonewax & Umbilical cotton tapes are GAMMA sterilized with a
contract facility.
All products are packed in 400/ 500gsm super chromo board carton. Twelve
foils are packed in a box and 30 /100 such boxes are packed in a master
carton. Master shippers are made of 5 ply board with burst strength of 20
Kg/Sq.cm.The shippers have dimensions of 54 x 33 x 33 cm weighing
approximately 10 kgs with product. However the pack size could be changed
depending the products ordered. Shippers are wrapped in weather resistant
stretch wrap film
Sutures
manufactured cater to all specialities, viz, General, Orthopaedic,
Gynaecology, Neurology, Urology, Cardio vascular, Ophthalmic etc.
For each product
(of a specific suture-needle combination) a minimum quantity of 100 doz.
need to be ordered.
Yes, the company
holds inventory of all the products as detailed in the product catalogs -
hosted in the Company's website. All customers can order these products from
the inventory available. There are no minimum order quantity restrictions
when ordered from the company inventory.
No, we are
working on it. This should be possible from year 2008.
The company
appoints distributors (1 per country) to distribute its products. The
distributor buys the products from the company & distributes. To
finalise the distribution, the company helps the prospective distributor
giving out samples for the hospital trial & also gives documents for
registration. Also after a year of continuous purchase the company helps the
distributor to participate in local surgical conferences. All quotations are
on FOB basis.
Samples &
certificates are given for tender participation along with special quotes -
depending on volume of tender enquiry.
The company
manufactures its own drilled end needles & therefore is the quickest to
supply sutures in the entire suture industry. Normally sutures are delivered
in 30 - 45 days depending on the volume. Delivery is effected by air.
The products are
extremely well accepted in European & American markets & compare to
multinational brands. The products are competitively priced.
Proforma Invoice
which gives the value of the products ordered is sent to the customers by
email. Freight as charged by the airline is added to the FOB prices. All
customers are required to open L/C for all supplies of over USD 10,000.
Payments below this value are to be paid in advance.
Meshes are
manufactured from biocompatible non absorbable undyed Polypropylene. Meshes
are USFDA & CE certified. Meshes are offered in 5 unique designs - Some
are thick, some are thin & pliable for laproscopic surgery, some have
bigger pores to allow better support in growth of tissues
Product FAQ's
No. We
manufacture natural rubber latex gloves of surgical grade , powdered. Low
powder, polymer coated, low protein gloves.
Surgical glove
sizes range from 6 to 8.5 in increments of 0.5. The variety of size options
ensures the best fitting glove will be available for every surgeon.
Yes
- It is Absorbable Corn Starch, U.S.P.grade.
- Powder Content not more than 15 mg/dm2
Gloves
manufactured by Truskin Gloves are 100% visually inspected for defects. In
addition, all glove lots are statistically sampled and tested for barrier
integrity.
Yes, the plant
is ISO 13485/2003 certified.
All
certificates are hosted on the company's website as Pdf files. These
certificates can either be downloaded or printed.
Yes, we can
manufacture Surgical gloves and packed in OEM to a third party, subject to
certain requirements.
Truskin Gloves
Private Limited is 100% subsidiary unit of Sutures India Pvt. Ltd.
Yes, if order
is placed in bulk and long term agreement
All surgical
gloves are sterilized and package sealed in pairs for individual use. The
sterilization of surgical gloves is standard as surgical procedures often
involve open wound operation. Gloves are sterilized by Ethylene Oxide gas or
Gamma Radiations as per customer req. Unless demanded it is EO. Sterility of
the product Complies with US Pharmacopoeia requirements.
One pair (1
left and 1 right) wrapped in a wallet & sealed in a peelable / tear
pouch, 50 such pouches packed in a Inner box and 8 inner boxes packed in
Export carton.
Special medical
grade paper is used, which permits complete sterilization of the product
and maintains the sterility throughout the shelflife of the product.
Powdered gloves
can be safely used for all types of surgeries & examination.
A minimum
quantity of 1,60,000 pairs needs to be ordered. At least to hold one 20'
container.
Yes, if the
goods are in Truskin brand
The company
appoints distributors to distribute its products. The distributor buys the
products from the company & distributes in his Country. All quotations
are on FOB, India basis.
Samples,
certificates and any other documents are given for tender participation as
per the tender requirements along with tender offers - depending on volume
the of tender inquiry
Normally gloves
are shipped with in 30 - 45 days depending on the quantity per size.
Shipment is effected by sea unless it is specially requested.
The products
are well accepted in European, Asian, African & American markets as
compared to other multinational brands.
Proforma
Invoice which gives the value of the products ordered is sent to the
Customers. Freight on actual is additionally added . If order value is above
USD 10000,confirmed irrevocable L/C at sight or remit 100% advance payment
is accepted. If ordered value is less than USD 10,000, then 100% payment has
to be paid in advance through Telegraphic Transfer.
- In 20' container : 2,00,000 pairs of tear open gloves & 1,60,000
pairs of peel open gloves will accommodate.
- In 40' container : 4,20,000 pairs of tear open gloves & 3,36,000
pairs of peel open gloves will accommodate
At present we
do not manufacture. By the mid of year 2009, You can send your enquiry for
the same.
Acceptable
Quality Level (AQL) - The AQL standard for surgical gloves will be
1.5.Our Medical Gloves are manufactured with minimal barrier defects such as
pinholes.
Natural creamy
white.
Five years
from the date of manufacture.
Below 150 μg/
dm2. Against the ASTM requirements of maximum 200 μg/ dm2
Gloves should
be stored in the inner box and should be kept in dry, cool and dust free
area. Gloves should not be stored near direct sunlight, moisture, X-rays or
extreme heat.
Some
Individuals may be sensitive to either the chemicals used in the
manufacturing of latex glove or the protein allergens in natural rubber
latex.
Yes!,
Left/Right Hand Fitted - In contrast to medical exam gloves, surgical
gloves are form fitted meaning every pair contains one glove shaped for the
left hand and one glove shaped for the right hand. This is to ensure the
highest level of comfort to help reduce fatigue from long surgical
procedures.
1.Tensile Strength? - The FDA requires surgical gloves to have
tensile strength of at least 24 MPa (before aging). The tensile strength of
the glove indicates the amount of force the glove can take before breaking.
The higher the tensile strength, the stronger the surgical glove is.
2.Elongation? - The FDA requires surgical gloves to have elongation
of at least 750% (before aging). The elongation measurement indicates how
far the glove can stretch before breaking. 750% elongation means the
surgical glove material must be able to stretch 7.5 times from its original
form. The higher the elongation measurement, the higher quality the surgical
glove is.
| FDA Requirements - ASTM Standards |
| Tensile Strength (before aging) |
24 MPa |
| Tensile Strength (after aging) |
18 MPa |
| Elongation (before aging) |
750% |
| Elongation (after aging) |
550% |
| What is distinct about LATEX Glove's manufacturing practices ? |
| With our state-of-art high technology and efficient automatic glove
manufacturing machines, we continue to obtain the most productive
manufacturing yield and to remain as one of the most cost-effective and
highest quality producer in the industry. |
All gloves are
size embossed. Size and customized printing can be done on special request
and additional cost.
With our
state-of-art high technology and efficient automatic glove manufacturing
machines, we continue to obtain the most productive manufacturing yield and
to remain as one of the most cost-effective and highest quality producer in
the industry.
Yes, all our
factories are certified with ISO 9002, EN46002 and we manufacture our
products strictly according to the GMP requirements.
Yes, our
gloves meet the ASTM D3578 (Examination Gloves) and ASTM D3577 (Surgical
Gloves). Besides the ASTM standards, our gloves have also surpassed the EN
455 Standards. Our Surgical Gloves have obtained the CE Mark and number i.e.
CE 0120.
Latex, being
the main raw material in rubber gloves manufacturing, is the gold standard
for durability. It demonstrates superior elasticity, strength and barrier
protection. It out performs vinyl as well as any synthetic rubber in terms
of maintaining barrier integrity in routine and high risks procedures.
Research shows that latex gloves provide up to 9 times more protection
during normal use than non-latex gloves.
Although the
effectiveness of gloves in preventing contamination, there is reasonable
chance of hand contact with blood or other body fluids, mucous membranes or
non intact skin. During performing invasive medical procedure and handling
to each patient.
- To reduce the risk of acquiring bacterial infection from Patients.
- To prevent staff or doctors from transmitting their skin flora to
patients
- To reduce contamination of the hands of staff caring patients
infected with certain pathogens from one patient to another.