3M
Technical Information Sheet
Product Number 1516
TM Single Coated Polyester Medical Tape
3M
Effective: February 2007
Supersedes all previous specifications
Features and Benefits:
Hypoallergenic Pressure Sensitive Adhesive
Occlusive
Low Profile
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-
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-
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Composition:
Tape Caliper
ETO, Gamma and Steam Compatible
Transparent
High Tensile Strength
Adhesive
2.3 mit (0.06 mm) Polyester Film Tape
Acrylate, designed for medical/surgical use
Backing
1.0 mil (0.03 mm) Transparent Polyester Film
Typical Properties:
Adhesion to Steel
Tensile Strength at Break
60 ounces/in (16.7 N/25 mm)
20 lb/in (89 N/25 mm)
+3M test methods are available upon request.
Roll Description: Tape supplied on 3 inch (76 mm) diameter cores.
Length
750 yards (686 m) ± 2% Maximum
Width
48 inch (122 cm) ± 1/32 in (1.0 mm)
Splices: Splices on the tape are intended for continuous processing.
Roll Width
Maximum Number of Splices per Roll
8 inch (20 cm)
2 per 100 yd (91 m)
5 per 400 yd (366 m)
8 per 750 yd (686 m)
Information on the splice frequency in roll widths greater than 8 inch (20 cm) is available upon
request.
Packaging and Recommended Storage:
Product as supplied in original packaging will maintain stated properties for a period of two years
from date stamped on shipping container when stored at temperatures between 50-80°F (10-27°C)
and a relative humidity between 40-60 percent.
Please see reverse side for important product, safety and warranty information.
0 3M 2007 All Rights Reserved.
3M Health Cr
Skin & Wound Care Division
Medical Specialnes
3M Ctntr
St. Paul Minnesota 55144-1000
65 1-733-1110
3M
28 March 2009
Dear Valued
3M Customer:
This letter is in response to your recent request for product composition information regarding the
Candidate List Substances (also Annex XIV Suhstances) related to the European REACH
Regulation No, 1907/2006 of the European Parliament and Council concerning the Registration.
Evaluation, Authorisation and Restriction of Chemicals (RfACll).
You requested information regarding the following 3M products;
•
•
•
•
3M’ Clear 2.3 mu Polyester Medical Tape without Liner 1516
3Mm” Transparent 44 all Polyethylene Medical Tape 1525L, 63 Liner
3MTh 4.4 niil Polyethylene Tape 9865A, 42# Liner
3MTh1 Transparent Polyethylene 4.9 mu, Double Coated, Medical Tape
9874, 60# Liner
Due to the wide variation in content and format of such request ibrms, it is 3M’s practice to
provide this formatted response to requests for REACH regulatory information.
To the best of 3M’s knowledge, the following chenticak, as eurrently listed in the SVHC
Candidate List, are not present at or above 0.1% in the products listed above:
Substanee
iriethyl arsenate
Anthrauen
Dihutyl phthalate (D9P)
(obalt Dichlortdc
Diarsenic Pentaoxide
Drnrsritc lrwt&
Sodiuni dichromate
5-tcrt-butyl-2,4.6-trinkro-rn-xy lene
(musk
yicne)
I3is(2Lh1(hv1)ptdhaiate) (DI HP)__________
1febroiocyloddccamc (HBCDD) and all
malor dias reomers identified (a-HBCDD. fI ICDD. y-1f[3CDD)
E(’ number
201-622—7
204-371-)
202-974-4
201.557-4
231 589-4
2)5-116-9
215 481-4
234-190-3
201 -329-4
204 211-0
247-148-4 and
221-695-0
CAS number
15606-95-8
120-12-7
101-77-9
84-74-2
7646 79 9
1303-28-2
1327 3 3
10588-01-9 and
778)-12-0
81-I 5-2
117—81 7
25637-99-4.
3194-55-6.
134237-50-6.
134237-5 1-7 and
134237-52-8
85535-84-8
A)kanes. Ci0-13. chloro (Shofl Chain 287-476-5
Chlorinated Paraffina)
Bis(tributyltin)oxide (IBTO)
200-268-0
56-35-9
Lead hydrugen arsenate
232-064—2
7784-40-9
Benl hutyl i,hthalate (BUP)
201 -622-7
85-68-7
please note that the substance list above is the Oct 2008 Candidate List: the content of the Candidate list an Annex
XIV may differ from each other and will both change over time,
3M Health Care
Skin and Wound Care L)ivnion
Medical Specialties
3M Center
St. Paul, Mrnnesota 55144-lOtlO
(>51-733-lI 10
3M
9 April 2009
Dear Valued 3M Customer:
letter is in response to your request for composition information regarding compliance of the
with the requirements of the European Union Directive 2002/95/tiC (RoHS)
and the related liuropean Union Directive 2002/96/EC (WEEE).
This
listed 3M product(s)
The
was prepared based on the best knowledge and understanding of the
and may be based in part on other infOrmation provided by 3M suppliers.
information
Division
Medical
Product:
3WM
Clear, 2.3 mu, Polyester Medical Tape without Liner, 116
Product Contains*: Yes/No
:
—
if yes level in wt. %.
Substance
Product Contains*
Level
Lead
Mercury
Cadmium
1-lexavalent Chromium
Pelybrominated iphenyls (PBB)
Polybrominated Diphenyl Ethers
(P13Dli
No
No
No
No
N/A
N/A
N/A
N/A
No
N/A
No
N/A
*
( ontams means that thc substanec is in the product ahoc the level ofO lob> t cxcept forcdmium htch n
001% by wi. Whilc the RollS Directive does HOL specify a de nihdmis threshold level, these maximum concentration
values (MCV are based on the Joint Industry Guide being considered for ratitication by the EQ Environmental
(ounCl. The MCV numbers are b> v.eight in the honmgcnous material.
If you need further information or have other related questions please contact me.
Sincerely,
I
‘2
Robert S. Dallinan
Affairs, Skin and Wound Care Division
3M Center. Bldg 275-5W-06
St. Paul MN 55144-1000
Tel: 65 1-736-1964; Fax: 651-737-5320
Email: rsdal1manjmmimcorn
Regulatory
iaaIhL
Ikaith r
3M
•cnw.r
133
in
4
PRODUCT CLINICAL DATA SUMMARY
NO. 1516
3M Plastic Medical Tape
Effective: January 1996
Page 2
21-day Cumulative Irritation in Humans
Protocol reference: Draize: Appraisal of the Safety of Chemicals in Food,
Drugs and Cosmetics (1965). Published by the Editorial Committee of the
Association of Food and Drug Officials of the United States.
Results: Probably mild irritant in normal use.
These tests are in accordance with the ISO 10993 Part-i “Biological Evaluations of
Medical Devices’, as put forth by the FDA. The components of No. 1516 has
satisfied the requirements for devices in contact with intact skin for short term
application (up to 29 days). All laboratory testing was conducted in accordance
with FDA Good Laboratory Practices Regulation of 1978.
The use of the term “hypoallergenic” has come to indicate a product which is non
sensitizing to the general public. The hypoallergenic claim for this product is
supported by clinical evaluation using the repeated insult patch test in humans,
commonly known as the Draize test. This protocol involves repeated application of
samples on 200 healthy volunteers for a 2- to 3-week induction period, followed by
a 2-week rest period and a challenge application. To be termed hypoallergenic, 3M
Medical Specialties products are required to show no evidence of sensitization
potential under these test conditions.
It is the responsibility of our customers to determine the final suitability of our
products for their application.
3M Health Care
Skn ni Wiun Lare Uvistn
Medical Spciais
3M Center
St. Paul. Mnnesota 55134-1000
5t433-1 110
3M
13 January 2009
I)ear Valued 3M Customer:
This letter will confinn that the products described below do not include as part of their
formulation or composition any hisphenol A (B PA) either directly or as a derivative of it.
Products:
3M1M
Transparent Polyethylene, 4.5 mit, Double Coated Tape 9889, 60#
Liner
3MM Clear 2.3 mu Polyester Medical Tape without liner 1516
This information was prepared based on the best knowledge and understanding of the
Skin and Wound Care Division and may be based. in part, on other information provided
by 3M suppliers.
If you have other related questions or need further information you may contact me at the
address shown below.
Sincerely.
/
/
/
-‘
Robert S. Dailman
Regulatory Affairs, Skin and Wound Care Division
3M Center, Bldg 275-5 W-06
SL Paul MN 55144-1000
Tel: 651-736-1964: Fax: 65l-737.5320
Email: rsdallmanimmmcom
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iiio
3M
January 11, 2008
Dear Valued Customer:
This letter is in response to your request, related to information concerning the use of
animal derivatives for 3M Medical Specialties product number 1516, Single Coated
Polyester Medical Tape.
3M Medical Specialties product #1516 does not contain any intentionally added animal
based components in the product or in packaging as we supply it.
If you have any additional questions regarding this or other 3M Medical Specialties
products, please contact Kristin Godbey, Senior Specialist Technical Service, at 1-651
733-9 146. Thank you for your interest in 3M Medical Specialties products.
Best regards,
Marcia Cartier
Clinical Research
270 4N 01
St. Paul, Minnesota 55 144-1000
C: K. Godbey
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11I( SpciaIties
3I lie hla (are
351
PL
s•r’
551 440O
1110
July 9, 2007
RE: Latex Free Material Confirmation
To whom it may concern:
Your request regarding the status of Medical Specialties Product #1516 Polyester
Medical Tape with regard to latex content was forwarded to me.
3M Medical Specialties product #1516 contains neither natural rubber latex nor dry
natural rubber as an intentionally added component in the product or in packaging as we
supply it. The splicing tape used in this product may contain a small amount of latex in
the adhesive. The splice tape is a common tape used in the converting process and
should be removed prior to end use.
If you have further questions regarding this or other products, please feel free to
contact Kris Godbey, Senior Technical Service Engineer at 651-733-9146, or myself at
651-737-1277.
Best Regards,
Marcia Cartier
Clinical Research
Bldg. 270-4N-01