Purchasing Department in Region of Southern Denmark 2015

Purchasing Department in Region of Southern Denmark 2015

Medical gloves for single use/Protective gloves, Powder-Free

Addendum 3 -4Protective gloves, nitrile, non-sterile, short

Please note: if the product is altered, the submission of a new form to Purchasing Department in Region of Southern Denmark and Konsulentfunktionen for Farlige Stoffer is required.

Questionnaire filled out by

Date
Signature

Supplier

Company name
Address
Postcode/Town
Telephone
E-mail
Contact
Date
Signature
Name of the glove as specified on the packaging
Available sizes
(minimum requirement: S-XL / 6,5-10) / According to European Standard EN 420
Glove manufacturer
Glove material / Nitrile
Thickness of the glove measured on a single layer in mm / Finger
Palm
Cuff
Is the glove supplied with a rolled bead cuff / Yes
No
Thickness of the rolled bead in mm
Length of the glove in mm (state for size 7½-8 / M. minimum requirement: min. 240 mm)
Colour of the glove
For non-sterile gloves / Dimension of the packaging: Height x width x length in mm
Is the glove dispen-sed one by one / Yes
No
Structure of surface / Rugged fingertips / Yes
No
Treatment of inner surface/-coating
- which
AQL – Tightness
(minimum requirement: ≤ 1,5) / Value according EN 455-1
State the Inspection Level and the sample size code letter according to ISO 2859-1
Force at break EN 455-2 in Newton
Protective gloves tested according to EN 455-2 and meeting these requirements are preferred / Force at break(min. ≥ 6)
Force at breakafter challange testing (min. ≥ 6)
Mechanical characteristics
EN 374-1 according to EN 388
To be stated in levels 1 – 5
(minimum requirement) / Abrasion
Blade cut
Tearing resistance
Puncture
Test for virus penetration
ASTM F 1671 (minimum requirement) / Requirementsmeet / Yes
No
Shelf life EN 455-4 / Expiry date stated on the packaging / Yes
No
Expiry date stated in the supplemen-tary document / Yes
No
Production date stated / On the packaging / Yes
No
In the supplemen-tary document / Yes
No
Is the glove approved for food / Yes
No

Possible allergenic agents in the glove:

1)Mark with an X which of the below mentioned agents have been used in the manufacture of the glove.

2)Specify the residue concentration measured in the finished glove.

PLEASE NOTE: Every single allergenic agent must appear in the table below, even though the residue concentration is below the lower limit of detection.

Thiurames

CAS number / Agent/synonym / Molecular formula / Used
yes no / Residue con. (mg/g or %) in the finished glove
97-74-5 / Tetramethylthiurammmonosulfide (TMTM) / C6H12N2S2
137-26-8 / Thirame; Tetramethylthiuramdisulfide (TMTD) / C6H2N2S4
97-77-8 / Disulfirame; Tetraethylthiuramdisulfide (TETD) / C10H20N2S4
94-37-1 / Bis(piperidinothiocarbonyl)disulfide; Dipentamethylthiuramdisulfide (DPTD) / C12H20N2S4
Or other chemical-related agents, which has to be stated below

Dithiocarbamates

CAS number / Agent/synonym / Molecular formula / Used
yes no / Residue con. (mg/g or %) in the finished glove
137-30-4 / Zirame; Zinkdimethyldithiocarbamate (ZDMC) / C6H12N2S4Zn
14324-55-1 / Zinkbis(diethyldithiocarbamate); Zinkdiethyldithicarbamate (ZDC, ZDEC) / C10H20N2S4Zn
136-23-2 / Zinkbis(dibutyldithiocarbamate); Zinkdibutyldithiocarbamate (ZBC, ZDBC) / C18H36N2S4Zn
14634-93-6 / Zinkbis(N-ethyl-N-phenyldithiocarbamate); Zinkethylphenyldithiocarbamate (ZEPC) / C18H20N2S4Zn
13878-54-1 / Zinkbis(piperidin-1-carbodithioat); Zinkpentamethylendithiocarbamate (ZPD) / C12H20N2S4Zn
14726-36-4 / Zinkbis(dibenzyldithiocarbamate); Zinkdibenzyldithiocarbamate / C30H28N2S4Zn
136-30-1 / Sodium dibutyldithiocarbamate (NBC) / C9H18NS2Na
Sodiumcyclohexylethyldithiocarbamate (NHEC)
Or other chemical-related agents, which has to be stated below

Thiurea compounds

CAS number / Agent/synonym / Molecular formula / Used
yes no / Residue con. (mg/g or %) in the finished glove
109-46-6 / 1,3-dibutyl-2-thiourea; Dibutylthiourea (DBTU) / C9H20N2S
105-55-5 / 1,3-diethyl-2-thiourea; Diethylthiourea (DETU) / C5H12N2S
102-08-9 / 1,3-diphenyl-2-thiourea;Diphenylthiourea (DPTU) / C13H12N2S
96-45-7 / Imidazolidin-2-thion;N,N’-ethylenthiourea; Ethylenthiourea (ETU) / C3H6N2S
Or other chemical-related agents, which has to be stated below

Mercaptobenzothiazole and derivatives

CAS number / Agent/synonym / Molecular formula / Used
yes no / Residue con. (mg/g or %) in the finished glove
149-30-4 / Benzothiazol-2-thiole; Mercaptobenzothiazol (MBT) / C7H5NS2
155-04-4 / Zinkdi(benzothiazol-2-yl)disulfide; Zinkmercaptobenzothiazole (ZMBT) / C7H5NS2x½Zn
102-77-2 / 2-(morpholinothio)benzothiazole; Morpholinylmercaptobenzothiazole (MOR, MBS) / C11H12N2OS2
120-78-5 / Di(benzothiazol-2-yl)disulfide; Dibenzothiazyldisulfide (MBTS) / C14H8N2S4
Diethylbenzothiazolsulfenamide (DEBS)
95-33-0 / N-cyclohexyl-benzothiazol-2-sulfenamid; N-cyclohexyl-2-benzothiazylsulfenamide (CBS) / C13H16N2S2
Dicyclohexylbenzothiazolesulfenamide (DCBS)
Or other chemical-related agents, which has to be stated below

Mercaptobenzimidazol

CAS number / Agent/synonym / Molecular formula / Used
yes no / Residue con. (mg/g or %) in the finished glove
583-39-1 / Benzimidazol-2-thiole / C7H6N2S

p-Phenylendiaminderivates

CAS number / Agent/synonym / Molecular formula / Used
yes no / Residue con. (mg/g or %) in the finished glove
101-72-4 / N-Isopropyl-N’-phenyl-p-phenylendiamine (IPPD) / C15H18N2
74-31-7 / N,N’-Diphenyl-p-phenylendiamine (DPPD) / C18H16N2
Or other chemical-related agents, which has to be stated below

Other chemical agents

CAS number / Agent/synonym / Molecular formula / Used
yes no / Residue con. (mg/g or %) in the finished glove
102-06-7 / 1,3-Diphenylguanidine / C13H13N3
123-31-9 / Hydroquinone / C6H6O2
92-88-6 / Biphenyl-4,4’-diol / C12H10O2
100-97-0 / Methenamine (hexamethylenetetramine) / C6H12N4
17796-82-6 / N-(cyclohexylthio)phthalimide / C14H15NO2S

Other chemical agents:

If chemical agents other than the above mentioned allergenic agents have been used in the production of the gloves and if these agents may cause any harm to human health, please specify these agents below with name (cas number if possible) and the residue concentration in the finished glove.

CAS number /

Agent/synonym

/ Residue con. (mg/g or %) in the finished glove
Name of the glove
Tenderer
Date

Addendum 3-409.01.15

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Purchasing Department in Region of Southern Denmark 2015

Medical gloves for single use/Protective gloves, Powder-Free

Chemical Breakthrough Times
Please provide information on all chemical tests performed on the glove. Gloves tested for hospital-relatedchemicals - such as cytotoxic drugs, antibiotics, formalin 4% and 37%, de 2% and organic solvents - are preferred.

Agent/product / Conc.
State unit
(1) / CAS Number
For pure agents and solution of agents / Break-through times
in minutes / Permeation performance
level / Mark with an X in test method / Mark with an X if the test is for
EN 374-3 / ASTM F739state the tempe-rature / Other, specify / The offered glove / A similar glove

1) If the test is not performed with the pure chemical (e.g a mixture), be sure to specify the concentration of the ingredients. E.g.: Hydrochloric acid 37%, 5-Fluoracil 50 mg/ml and acetonitrile 73% + methanol 25% + ammonia 2%

Agent/product / Conc.
State unit
(1) / CAS Number
For pure agents and solution of agents / Break-through times
in minutes / Permeation performance
level / Mark with an X in test method / Mark with an X if the test is for
EN 374-3 / ASTM F739 state the tempe-rature / Other, specify / The offered glove / A similar glove

1) If the test is not performed with the pure chemical (e.g a mixture), be sure to specify the concentration of the ingredients. E.g.: Hydrochloric acid 37%, 5-Fluoracil 50 mg/ml and acetonitrile 73% + methanol 25% + ammonia 2%

Name of the glove
Tenderer
Date

Addendum 3-409.01.15

Page1of7