G/TBT/N/THA/597  
9 March 2021  
(21-1967) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  THAILAND   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Thai Industrial Standards Institute (TISI), Ministry of Industry  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated  if different from above:   
WTO/TBT Enquiry Point and Notification Authority  
Thai Industrial Standards Institute (TISI), Ministry of Industry  
Tel.: (662) 202 3504, 202 3523  
Fax: (662) 202 3511, 354 3041  
E-mail: thaitbt@tisi.mail.go.th  
Website: http://www.tisi.go.th  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Single -
use medical examination gloves  
5. Title, number of pages and language(s) of the notified document:  Draft Ministerial 
Regulation on Single -use medical examination g loves - Part 1: Specification for gloves 
made from rubber latex or rubber solution (TIS 1056 -1:2556(2013)) (13 page(s), in Thai)  
6. Description of content:  The draft ministerial regulation mandates single -use medical 
examination gloves to conform with the  standard for Single -use medical examination 
gloves - Part 1: Specification for gloves made from rubber latex or rubber solution (TIS 
1056 Part 1 - 2556(2013)).  
This standard specifies requirements for packaged sterile or bulked nonsterile, rubber 
gloves intended for use in medical examinations and diagnostic or therapeutic procedures 
to protect the patient and the user from cross -contamination. It also covers rubber gloves 
intended for use in handling contaminated medical materials and gloves with smooth 
surfaces or with textured surfaces over all or part of the glove.  
The content and structure of the standard are identical to ISO11193 -
1:2008/Amd.1:2012(E).   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  G/TBT/N/THA/597  
 
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  8. Relevant documents:   
• ISO 37, Rubber, vulcanized or thermoplastic – Determination of tensile stress – 
strain properties  
• ISO 188, Rubber, vulcanized or thermoplastic – Accelerated ageing and heat 
resistance tests  
• TIS 465, Sampling procedures for inspection by attributes - Part 1: sampling 
schemes indexed by acceptance quality limit (AQL) for lot -by-lot inspection  
• TIS 2395, Biological evaluat ion of medical devices  
• ISO 15223, Medical devices – Symbols to be used with medical devices labels, 
labelling and information to be supplied  
• ISO 23529, Rubber – General procedures for preparing and conditioning test 
pieces for physical test methods  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  120 days after its publication date on the 
Government Gazette  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO/TBT Enquiry Point and Notification Authority  
Thai Industrial Standards Institute (TISI), Ministry of Industry  
Tel.: (662) 202 3504, 202 3523  
Fax: (66 2) 202 3511, 354 3041  
E-mail: thaitbt@tisi.mail.go.th  
Website: http://www.tisi.go.th  
https://members.wto.org/crnattachments/2021/TBT/THA/21_1787_00_x.pdf