Merufa Gloves - Custom Documents

 

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