BỘ Y TẾ VIỆT NAM VIET NAM MINISTRY OF HEALTH
CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness Ha Noi , date 15month %
04 year
2020
GIẤY CHỨNG NHẬN LƯU HÀNH TỰ DO CERTIFICATE OF FREE SALES 1. Giấy chứng nhận số/Certificate No:
20000004CFS/BYT-TB-CT
$
2. Sản phẩm/Product(s): GĂNG phẩm/Product(s): GĂNG PHẪU THUẬT (Surgical Gloves) 3. Chủng loại/Model: GPT loại/Model: GPT 4. Công ty sở hữu hợp pháp: CÔNG pháp: CÔNG TY CỔ PHẦN MERUFA - Product(s) Owner: MERUFA Owner: MERUFA JOINT STOCK COMPANY - Địa chỉ : 38 Trương Quốc Dung, Phường 08, Quận Phú Nhuận, Thành phố Hồ Chí Minh - Address : 38 TRUONG QUOC DUNG STREET, WARD 8, PHU NHUAN DISTRICT, HO CHI MINH CITY, VIET NAM 5. Công ty sản xuất: CÔNG xuất: CÔNG TY CỔ PHẦN MERUFA - Manufacturer: MERUFA Manufacturer: MERUFA JOINT STOCK COMPANY
- Địa chỉ: 38 chỉ: 38 TRƯƠNG QUỐC DUNG, Phường 08, Quận Phú Nhuận, Thành phố Hồ Chí Minh - Address: 38 Address: 38 TRUONG QUOC DUNG STREET, WARD 8, PHU NHUAN DISTRICT, HO CHI MINH CITY, VIET NAM Văn này đương là để xác nđược hận rằng trên tu tuân ân theo tiêusản chuẩn qu quan anbịcủa Nam hoặcbản tương và nhận phépcác phép bánsản tại phẩm Việt Nam. Việc xuấtcác khẩu phẩm phẩmliên không hạnViệt chế. This is to certify that the above product(s) comply with the relevant standards of the S.R. Vietnam or equivalent and are allowed to be sold in Vietnam. The exportation of the product(s) is not restricted.
Giấy chứng nhận này có hiệu lực 03 năm kể từ ngày ký. This certificate is vaild for three years from the date of issuance. KT. BỘ TRƯỞNG THỨ TRƯỞNG FOR MINISTER OF HEALTH DEPUTY MINISTER OF HEALTH
Nguyễn Trường Sơn
MEDICAL GLOVES BOX (LONG SLEEVE)
SPECIFICATION: 260*120*65mm PAPER TYPE: DUBLEX basing on the standards issued by the manufacturer COLOR: Green (Refer to the attached sample, color shall not be changed) Size: S, M, L
(Please refer to the Vietnamese version for your detail)
MERUFA JOINT STOCK COMPANY GENERAL DIRECTOR
(signed and sealed) LUU TIEN CAO, B.A.
SPECIFICATION: 230*120*65mm PAPER TYPE: DUBLEX basing on the standards issued by the manufacturer COLOR: Green, brown, red Size: S, M, L, X-S X-S (This is to adjust the word “M“M-medium” at hand frame image f o orr appropriate with the size)
(Please refer to the Vietnamese version for your detail)
MERUFA JOINT STOCK COMPANY GENERAL DIRECTOR (signed and sealed)
LUU TIEN CAO, B.A.
QUATEST 3®
DIRECTORATE FOR STANDARDS, METROLOGY AND QUALITY
QUALITY ASSURANCE AND TESTING CENTER 3 KT3-00395AHD9/1
TEST REPORT
15 February 2019 Page: 01/02
1. Name of sample
: EXAMINATION GLOVES USED FOR MEDICAL INDU INDUSTRY STRY
2. Quantity
: 01
3. Description
:information Testing sample sampled by customer, sample name and sample were was supplied by customer. 20 pairs of glove
4. Date of receiving
: 21 January 2019
5. Customer
MERUFA JOINT STOCK :38 Trung Quoc Dung, WardCOMPANY 8, Phu Nhuan District, Ho Chi Minh City
6. Test period
: 22 February 2019 – 2019 – 15 15 February 2019
7. Test result
: See page 02/02
HEAD OF CONSUMER PRODUCTS TESTING LAB. (signed) NGUYEN PHUOC HAI
PP. DIRECTOR HEAD OF TESTING LAB. (signed and sealed) PHAN THANH TRUNG
1. Test result are valid for the namely submitted sample(s) only. 2. This Test Report shall not reproduced, except in full, without the written permission by Quatest 3. 3. N/A: Not applicable.
4. Name of sample(s) and customer are written as customer ’s ’s request. request. 5. Estimated expanded uncertainty of measurement with k = 2, at 95% confidence level. Please contact Quatest 3 at the below address for further information. Head office: Testing:
49 Pasteur, Dist. 1, HCMC, Vietnam No. 7, road No. 1, Bien Hoa 1 IZ, Dong Na, Vietnam C5 lot, K1 road, Cat Lat IZ, Dit.2, HCM, Vietnam
Tel.: (84-28) 3829 4274 Tel: (84-251) 383 6212 Tel: (84-28) 3742 3160
Time of revision: 0
Fax: (84-28) 3829 3012 Fax: (84-251) 383 6298 Fax: (84-28) 3742 3174
BH12 (July 2018)
Website: www.quatest3.com.vn www.quatest3.com.vn E-mail: tnE-mail:
[email protected] [email protected] Email: tnEmail:
[email protected] [email protected]
M03/1-TTTN09
QUATEST 3®
DIRECTORATE FOR STANDARDS, METROLOGY AND QUALITY
QUALITY ASSURANCE AND TESTING CENTER 3 KT3-00395AHD9/1
15 February 2019 Page: 02/02
TEST REPORT
Ageing condition: At 70 oC for 168 hours. Test result Characteristic
Test
method
7.1 Force at break, N
Quantity of specimen
Mean value
Min value
Max value
5
8.0
7.6
8.4
ISO 37: 2011
Before ageing
7.6
After ageing
7.2 Elongation at break, %
5
6.8
6.2
ISO 37: 2011
Before ageing
5
720
700
770
After ageing
5
680
570
750
7.3 Dimension, mm
TCVN 63431:2007
Width
98
97
98
Length
250
248
252
Thickness at, mm
a. Finger
0.1
0.09
0.12
b. Palm
0.08
0.08
0.09
c. Cuff
0.07
7.4 Watertightness,
TCVN 63431:2007
Number of defects
0.06
20
0.07
0
Note: The number of test specimen has been be en specified by customer.
QUATEST3®
DIRECTORATE FOR STANDARDS, METROLOGY AND QUALITY
QUALITY ASSURANCE AND TESTING CENTER 3 Head office: Testing:
49 Pasteur, Dist. 1, HCMC, Vietnam No. 7, road No. 1, Bien Hoa 1 IZ, Dong Na, Vietnam
Tel.: (84-28) 3829 4274 Tel: (84-251) 383 6212
Fax: (84-28) 3829 3012 Fax: (84-251) 383 6298
Website: www.quatest3.com.vn www.quatest3.com.vn E-mail: tnE-mail:
[email protected] [email protected]
C5 lot,HCM, K1 road, Cat Lat IZ, Dit.2, Vietnam
Tel: 3160(84-28) 3742
Fax: 3174(84-28) 3742
Email: Email:
[email protected] [email protected]
Time of revision: 0
BH12 (July 2018)
M03/2-TTTN09
APPENDIX VIII FORM OF TECHNICAL DOCUMENTATION OF MEDICAL FACILITIES (Promulgated in conjunction with Decree No. 36/2016/ND-CP issued 15 May 2016 by the Government) --------------------------------------------------Form No. 1
DESCRIPTION OF TECHNICAL SUMMARY OF MEDICAL FACILITIES Name of circulation registration establishment of medical facilities: MERUFA JOINT STOCK COMPANY Address: 38 Truong Quoc Dung, Ward 8, Phu Nhuan District, Ho Chi Minh City Ho Chi Minh City, 05 June 2019 No. 1
Title
Content of description of summary
Description of medical facilities product Materials
Examination gloves (examination (examination gloves
used for the medical industry, long-sleeve medical gloves) made out of natural rubber latex. Type
- Examination designs:
gloves
include
many
Smooth surface, straight fingers
Smooth surface, textured finger end
- Examination gloves are pre-powdered
1.1
( Modified Modified Corn Starch, the type which can be absorbed by body solution, achieving the US USP pharmacopoeia standards).
Description of medical facilities
- Non-sterile gloves - Used for both hands - Disposable gloves. Standard of - Conformance with the standards TCVN 6343-1:2007, international standard ISO quality 11193-1:2002
- American Standard ASTM D3578-05 Size of glove
Gloves include many sizes: Ultra-small (XS), small (S), medium (M), large (L), ultra-jumbo (XL)
Maintenance
Shelf life
Maintenance is done at the dry, clear place, where has the temperature not more o than 30 C, protection from direct sunlight. 05 years since the manufacturing date
1.2
List of components accessories (including associated chemicals)
1.3
Use purpose/ indication is shown - Examination gloves are the packaging type, non-sterile, on the label
1.4
Instructions for use
and None the
they are used during disease examination and diagnosis or treatment, for avoiding from the communicable disease, bacteria, virus and so on between the patient and user. - After wearing gloves, cleaning all powder outside by the sterilized moist foaming piece or wet soft towel or by another useful method. Using for both left and right hand (ambidextrous). -- Non-sterile. - Disposable gloves. - Examination gloves are used for the medical industry for replacement for the surgical gloves (when direct operation for the patient).
1.5
Contraindication
Gloves are made out of natural rubber latex, therefore, they may cause allergy for some persons whose body are allergic to rubber. Although, MERUFA has applied the advanced technologies for eliminating most of agents
which cause allergic in the products, however, because of safe reason, MERUFA recommends that the persons whose body are allergic to natural rubber, such persons should not use (basing on the recommendation of World Health organization – organization – WHO) WHO) 1.6
Warning and precaution
- Not further using the pre-powdered of unsafe type for easy to wear gloves (it ( it can cause allergic, infected, …) …) - Not used the torn, holed gloves or gloves ’ expiry date ended. - Not using gloves in the petroleum, oil environment and chemical corrosive. - After using, gloves must be destroyed in the burner of medical trash in accordance with the regulations of Ministry of Health.
1.7
2
Specific adverse effect which None may occurs
I nf nforma ormati tion on o off pr prod oducts ucts a arr e ci cirr culat culate ed i n the countr countrii es (if any) The product of examination gloves used for the medical industry is used broadly at all countries in the world, in which, including Vietnam.
3
Indication has been registered in other countries (if any)
List all countries where issued the circulation registration in conjunction with the use indications approved in such country, date of issued registration. 4
Notable information of safety / operation of medical facilities product
Note: See Item 1.6 Circulation registration establishment commits that the foregoing contents are true and correct and assumes the responsibility for law of the above-declared information. The legal representative of establishment Sign (full name, title) It is certified by stamp or digital signature GENERAL DIRECTOR (signed and sealed) LUU TIEN CAO, B.A
MERUFA Since 1987
MERUFA JOINT STOCK COMPANY 38 Truong Qoc Dung, Ward 8, Phu Nhuan District, Ho Chi Minh City Factory: C64/II, Street No. 8 – 8 – Vinh Vinh Loc A Industrial Park A, Binh Chanh, Ho Chi Minh City Tel.: (84-28) 3765 4160. Fax: (84-28) 3765 4161
Website: www.merufa.com.vn . E mail: mail:
[email protected] [email protected] -------------------------------------------------------------------
TECHNICAL SPECIFICATIONS OF EXAMINATION GLOVES (EXAMINATION (EXAMINA TION GLOVES, LONG-SLEEVE MEDICAL GLOVES)
I. DESIGN OF GLOVES No.
Item
1
Type
2
Design
3
Finish
Description
Type 1 – Made Made out of natural rubber latex Straight finder
Textured outside surface
Smooth outside surface
Pre-powdered
Powderless
4
Standard of quality
5
Maintenance
Remark
ISO 11193-1:2002, TCVN 6343-1:2007, ASTM D 357805
Maintenance is done at the dry, clear and clean place, o temperature isn’t more than tha n 30 C, protection from direct sunlight
II. THE APPLIED REGULATIONS FOR CHECKING THE PRODUCT BATCH (PURSUANT TO ISO 2859-SAMPLING PROCEDURES AND TABLE FOR INSPECTION)
Inspection level
No.
Characteristic
1
Physical dimensions (Width W, Length-L, Thickness-T) Hole on surface of gloves (test by water) (Water-tightness) Force at break, elongation at
2
3
break [before and accelerated ageing]
AQL MERUFA TCVN 6343-1
S-2
ISO 11193-1 4.0
4.0
G-I
2.5
2.5
S-2
4.0
4.0
Remark
after
III. SIZE CODE AND DIMENSION OF EXAMINATION GLOVES MANUFACTURED – MANUFACTURED – PROVIDED BY MERUFA Minimum length mm Size code
Description of size code
6 (and
XS (Ultra-
Width
≤82 ≤82
ISO 11193 TCVN 6343 ASTM D3578 220
MERUFA
Minimum single wall thickness required mm ISO ASTM 11193-1 D3578-05 TCVN 6343-1
220 Applied
Remark
smaller) 6
small) S
7 7 8 8 9 (and
(Small) M (Medium) L (Large) XL (Ultra-
larger)
jumbo)
83±5
220
89±5 95±5 102±6 109±6 ≥110 ≥110
230 230 230 230 230
230
240
for sizes. - At smooth area: 0.08 - At textured area: 0.11
- At finger: 0.08 - At palm: 0.08
REMARK:
Long-sleeve medical gloves includes “Classification of size code”, “width”, “thickness” (applied ( applied for each size code) the same as the examination gloves, but length of sleeve is longer. The minimum length of long-sleeve medical gloves is shown as follows: 285 ±10mm.
IV. PHYSICO-MECHANICAL PROPERTIES OF MERUFA GLOVES No.
Property
TCVN 6343-1
ASTM
ISO 11193-1
D3578-05
1
Minimum force at break before accelerated ageing
7.0 N
18MPa
2
Minimum force at break before accelerated ageing
650%
650%
3
Minimum force at
6.0N
14MPa
break after
Remark
