THAILAND · MEDICAL DEVICES

Thailand Medical Mask, N95 and Gown Standards: The Accepted Routes in the 2026 Notification

For medical face masks, medical N95 masks, surgical gowns and medical coveralls, the standards Thailand accepts are set out in the annex to the Ministry of Public Health notification on medical device standards, B.E. 2569 (2026). The notification took effect on 3 November 2026.

For each of the four products, the annex lists several compliance routes as alternatives. US, European, Chinese and Thai standards appear side by side, and each list ends with “other equivalent standards”. (Source: Thai FDA notification page, annex items 18–21)

Accepted standards at a glance

Each list also allows “other equivalent standards”. The listed editions are followed by “or later” wording.

Surgical gowns and isolation gowns (item 18)

The annex defines these as long-sleeved gowns that cover the body from the chest to the legs, with close-fitting cuffs, worn to prevent or reduce contamination by liquids, secretions, blood or pathogens between patients and medical personnel.

The product must follow one of these routes:

1. ANSI/AAMI PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes in Health Care Facilities, or later — the Barrier performance section;
2. EN 13795-1:2019, Surgical clothing and drapes – Requirements and test methods – Surgical drapes and gowns, or later — the Performance requirements section;
3. YY/T 0506.2-2016, Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment – Part 2: Performance requirements and test methods, or later — the Performance requirements section;
4. other equivalent standards.

Medical coveralls (item 19)

The annex defines a coverall as a garment with long sleeves and legs that covers the whole body from head to foot, with close-fitting cuffs, worn for the same protective purpose.

The product must follow one of these routes:

1. ANSI/AAMI PB70:2012, or later — the Barrier performance section;
2. EN 14126:2003, Protective clothing – Performance requirements and tests methods for protective clothing against infective agents, or later — the section on performance requirements against penetration by infective agents;
3. GB 19082-2009, Technical Requirements for Single-use Protective Clothing for Medical Use, or later — Liquid barrier performance, Filtering efficiency, Resistance to flame, Antistatic property, Electrostatic decay and Skin irritation;
4. other equivalent standards.

Single-use medical face masks (item 20)

The product must follow one of these routes:

1. Thai Industrial Standard TIS 2424-2565, single-use medical face masks, or as later announced — excluding the marking and labelling section;
2. ASTM F2100-25, Standard Specification for Performance of Materials Used in Medical Face Masks, or later;
3. EN 14683:2025, Medical face masks – Requirements and test methods, or later;
4. YY 0469-2023, Surgical mask, or later;
5. other equivalent standards.

Single-use medical face masks, N95 or higher (item 21)

This item covers single-use masks for medical use, as defined in the annex: masks that fit closely over the nose and mouth, with a particle filtration efficiency of at least 95 per cent, fluid resistance and fit testing. It is not a general category for industrial respirators.

The product must follow one of these routes, as applicable:

1. TIS 2480-2562 (N95), or as later announced — excluding marking and labelling;
2. TIS 3189-2564 (N99), or as later announced — excluding marking and labelling;
3. TIS 3190-2564 (N100), or as later announced — excluding marking and labelling;
4. US FDA, Guidance for Industry and FDA Staff, Surgical Masks – Premarket Notification [510(k)] Submissions (5 March 2004), or later — Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure (Delta-P) Test and Flammability Testing.
   • Particulate Filtration Efficiency must be tested under NIOSH 42 CFR Part 84, section 84.174 (Filter efficiency level determination test – non-powered series N, R and P filtration).
   • A pass under NIOSH 42 CFR Part 84, section 84.172 (Airflow resistance test) may be used in place of the Delta-P test.
   • If these NIOSH provisions are revised or amended, the newer provisions may also be used.
5. EN 149:2001+A1:2009, Respiratory protective devices – Filtering half masks to protect against particles, or later — Practical Performance, Total inward leakage, Penetration of filter material, Compatibility with skin, Flammability, Carbon dioxide content of the inhalation air, Exhalation valve(s), Breathing resistance and Clogging; and EN 14683:2019+AC:2019, Medical face masks – Requirements and test methods, or as later announced — Splash resistance (tested only for masks with Type IIR protection) and Bacterial filtration efficiency (BFE);
6. GB 19083-2010, Technical Requirements for Protective Face Mask for Medical Use, or later — Filtering efficiency, Gas flow resistance, Synthetic blood penetration, Surface wetting resistance, Flame retardation and Skin irritation;
7. other equivalent standards.

What this means for your test reports

• Pick one route and cover all of it. The annex asks for conformity to one of the listed entries. An entry can contain more than one standard, named test items and conditions, and all of them apply. A product that follows a listed US, European or Chinese route does not also need testing to the Thai Industrial Standard for the purpose of this notification.
• The European N95 route needs two standards. EN 149 alone is not enough. The entry also requires splash resistance (for Type IIR) and BFE under EN 14683.
• Check the test items named. For several standards the annex names specific sections or test items. Confirm that your report covers each one.
• Check the edition. The annex names specific editions and accepts later ones. Note that item 20 names EN 14683:2025 while item 21 names EN 14683:2019+AC:2019. If your report follows an earlier edition than the one named, raise this before filing.
• GB 19083 is the listed Chinese route for N95-type masks. It is not the same as NIOSH approval, and GB 2626, the standard under which KN95 is a filter class, is not named in the list. Relying on it would mean showing equivalence.
• “Equivalent” needs support. If you rely on a standard that is not listed, be ready to show how it is equivalent.
• Registration review still applies. Following a listed route satisfies the standard requirement in this notification. The Thai FDA still reviews the registration file as a whole.

Transition

Licence, detailed notification and listing holders who were already manufacturing or importing these products before 3 November 2026, and who intend to continue, have one year from that date to comply. This does not extend to new applicants. Applications filed earlier and still under review are treated as filed under the new notification. For the full transition rules and the other 17 product categories, see Thailand medical device standards 2026.