Face masks, gloves and PPE: when MDA registration applies.
The same mask or glove can be a regulated medical device or an ordinary industrial product. The difference is what the manufacturer claims. Here is where MDA draws the line, the minimum standards it sets for each type of medical PPE, and what registration takes.
Medical claims make it a medical device.
MDA regulates face masks, respirators and other personal protective equipment (PPE) as medical devices when the manufacturer’s labelling, advertising or documentation claims a purpose that fits the definition in section 2 of Act 737: typically preventing the transmission of disease (including COVID-19), or surgical or clinical use. Those products must be registered before they are imported, exported or sold. The same products marketed for construction, chemical handling or other industrial use, with no medical claim, are ordinary PPE that MDA does not regulate.
Two MDA guidance documents set the requirements: MDA/GD/0033, Medical Face Mask and Respirator (Third Edition, 18 May 2023), and MDA/GD/0058, Personal Protective Equipment (PPE) – Requirements (Second Edition; the cover is dated 10 May 2022 and MDA’s list gives 27 May 2022). Each lists, by product type, the minimum standard the product must meet and what its label should say.
Medical or not: where MDA draws the line
| Product and claim | Status | Source |
|---|---|---|
| Medical mask, surgical mask or surgical respirator for medical use | Medical device | MDA/GD/0033; MDA/GD/0063 item 138 |
| Industrial disposable mask, firefighter mask, disposable dust mask | Not a medical device | MDA/GD/0063 item 139 |
| Respirator for construction sites or factories, against dust and debris | PPE, not regulated by MDA | MDA/GD/0033 clause 1 |
| Gloves labelled “surgical” or “examination”, or otherwise for a medical purpose | Medical device | MDA FAQ (technical evaluation); MDA/GD/0063 item 22 |
| Surgical apparel: shoe covers, surgical gowns and aprons, caps | Medical device | MDA/GD/0063 item 67 |
| Gowns, coveralls, gloves, face shields or goggles for chemical handling, construction or other industry | Not regulated by MDA | MDA/GD/0058 clause 1 |
MDA’s FAQ adds that “medical use” printed on the outer box has to match an intended use that fits section 2. Putting a medical claim on an industrial product brings it under Act 737.
Face masks and respirators (MDA/GD/0033)
Following WHO, MDA splits medical face masks into two types, both used in clinical and healthcare settings. Medical masks are regulated as Class A.
| Type | Use | Minimum performance (any one) | Label should show |
|---|---|---|---|
| Procedure mask / respirator | Patient procedures and isolation: clean environments, sterile cores, processing departments, ER and ICU bedside procedures | EN 14683:2019 Type I or Type II; ASTM F2100-19 Level 1; YY/T 0969 with 95% BFE; or an equivalent standard with comparable performance | Description of the mask and its BFE (%) |
| Surgical mask / respirator (fluid resistant) | Operating rooms and other sterile procedure areas; also protects the wearer from splashes of potentially contaminated liquids | EN 14683:2019 Type IIR; ASTM F2100-19 Level 2 or 3; YY/T 0469 with at least 98% BFE; or an equivalent standard with comparable performance | “Type IIR” or “Level 2/3”, or a description such as “splash” or “fluid resistant”, and the BFE (%) |
Both must also meet MDA’s labelling requirements. GD/0033 Table 2 compares the test limits:
| Test | EN 14683 Type I | Type II | Type IIR | ASTM F2100 Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|---|---|
| Bacterial filtration efficiency (BFE) | ≥95% | ≥98% | ≥98% | ≥95% | ≥98% | ≥98% |
| Particle filtration efficiency (PFE) | Not required | ≥95% | ≥98% | ≥98% | ||
| Synthetic blood penetration | Not required | Pass at ≥16.0 kPa | 80 mmHg | 120 mmHg | 160 mmHg | |
| Differential pressure (breathability) | <40 Pa/cm² | <60 Pa/cm² | <5.0 mmH₂O/cm² | <6.0 mmH₂O/cm² | ||
| Microbial cleanliness | ≤30 cfu/g | Not required | ||||
| Flammability | See the EU medical device directive | Class 1 (≥3.5 seconds) | ||||
Biocompatibility is evaluated to ISO 10993 for all of them. Table 2 also covers the Chinese standards YY 0469 (surgical mask) and YY 0969 (single-use medical mask) and the sampling plans (ISO 2859-1 or ANSI/ASQC Z1.4; 32 masks for synthetic blood, passing at 29 or more).
Respirators. GD/0033 defines a respirator as a respiratory protective device designed for a very close facial fit and very efficient filtration of airborne particles, and groups medical respirators with the matching mask type in Table 1. Its Annex A reproduces WHO’s advice that health workers performing aerosol-generating procedures wear an N95, N99, FFP2 or FFP3 respirator. MDA’s FAQ applies the same claims test to KN94 masks.
Gowns, gloves and other PPE (MDA/GD/0058)
GD/0058 covers the PPE used in healthcare institutions. Each item is a medical device if its intended use fits section 2, and must meet at least one of the listed standards (Table 1):
| Item | Intended use | Minimum standard |
|---|---|---|
| Non-surgical gown | Patient procedures and isolation (clean areas, ER and ICU bedside procedures); not for surgery, invasive procedures or medium-to-high contamination risk | ANSI/AAMI PB70 Level 1 or 2, or EN 13795 |
| Surgical or isolation gown | Operating rooms and sterile procedure areas; medium-to-high contamination risk; protects against blood-borne pathogens | ANSI/AAMI PB70 Level 3 (Level 4 recommended), or EN 13795; plus EN 556 if sterile |
| Coverall | High-risk situations and environments, such as a pandemic, against microorganisms in blood and body fluids | EN 14126 with ISO 16603 and ISO 16604 (Class 5 or 6); or EN 13795 with ISO 22610 and ISO 22612 (high performance); or ANSI/AAMI PB70 Level 4 at least |
| Apron | Patient procedures and isolation; not for surgery or medium-to-high contamination risk | EN 14126, ANSI/AAMI PB70 Level 1 or 2, ASTM F2407 Level 1 or 2, or EN 13688; plus ISO 7765-1 (impact) and ISO 6383-2 (tear). If biodegradable: EN 13432 or ASTM D6400 |
| Head cover | Two-way barrier between patient and healthcare provider during examination or treatment | ISO 13688 and EN 14126. If biodegradable: EN 13432 or ASTM D6400 |
| Shoe cover | Keeps tracked-in dirt and microbes out of theatres, clean rooms and hygienic areas; protects the wearer from spills and body fluids | EN 14126 and ISO 13688. If biodegradable: EN 13432 or ASTM D6400 |
| Examination gloves (non-sterile) | Procedures that do not need sterile conditions, such as drawing blood | ISO 11193 (all parts, as appropriate), EN 455 (all parts), or ASTM D6319, D3578, D5250 or D6977 as appropriate |
| Surgical gloves (sterile) | Barrier against disease transmission between staff and patients during surgery | ISO 10282, EN 455 (all parts) or ASTM D3577; ISO 11607 for sterility |
| Face shield | Protects the eyes from splashes and droplets during surgical or invasive procedures or high contamination risk | EN 166 or equivalent, plus ISO 10993-10 and ISO 10993-23 |
| Goggles | As face shields | EN 166 or equivalent, plus ISO 10993-10 and ISO 10993-23 |
Every item must also comply with MDA’s labelling requirements, and GD/0058 expects the label to describe the product and the level, class or sterility it claims (for example “surgical gown, Level 3”, or “medical examination gloves, non-sterile”).
The AAMI PB70 levels in GD/0058
- Level 1, minimal risk: basic care, standard isolation, cover gowns for visitors, a standard medical unit.
- Level 2, low risk: blood draws, suturing, the ICU, a pathology lab.
- Level 3, moderate risk: arterial blood draws, inserting an IV line, the emergency room, trauma cases.
- Level 4, high risk: long, fluid-intense procedures, surgery, when pathogen resistance is needed or non-airborne infectious diseases are suspected.
Classes and the route to registration
| Product | Class | Route |
|---|---|---|
| Medical face masks | A (MDA/GD/0033) | Direct to MDA in MeDC@St, no CAB (Exemption Order 2024 para 5), with the complete test report |
| Examination gloves | A (MDA/GD/0009 Rule 5; MDA/GD/0062) | |
| Surgical gloves | B (MDA/GD/0009 Rule 6: surgically invasive, transient use) | CAB conformity assessment first, by verification or full assessment |
| Gowns, coveralls, aprons, covers, face shields, goggles | Classify each under MDA/GD/0009 on its intended use | Class A direct to MDA; any higher class through a CAB |
Class A still needs evidence. Both guidance documents say that although Class A registration needs no CAB assessment, the establishment must submit the complete test report to MDA during registration. Class A is a full application, not a notification: MDA’s fees have been RM500 to apply and RM750 to register since 1 January 2026, and the manufacturer needs a quality management system certificate. Our Class A page walks through the form.
Several pack sizes of one product can share an application. Other differences, such as materials, are allowed in one family only where MDA/GD/0005’s closed list of permissible variants names them for that product type; see grouping. Each registered product carries its MDA registration number on the label (see labelling requirements).
Who does what
- Registration is made by the manufacturer if it is in Malaysia, or by the authorised representative of a foreign manufacturer.
- Importers and distributors need an MDA establishment licence, which requires GDPMD certification.
- Exports count. Act 737 section 5 covers export as well as import and supply; see our Certificate of Free Sale and export page.
- Advertising a medical mask or glove with medical claims is advertising a medical device; see advertisement approval.
Points the guidance is specific about
- The standard lists are minimums, and both documents accept an equivalent standard that gives comparable performance.
- Biodegradable aprons, head covers and shoe covers must also meet a compostability standard (EN 13432 or ASTM D6400).
- Sterile items need a sterility standard on top: EN 556 for surgical gowns, ISO 11607 for surgical gloves.
- GD/0033 still describes masks in the context of COVID-19 and reproduces WHO’s December 2020 advice. The registration requirements in Tables 1 and 2 do not depend on the pandemic.
Adakah pelitup muka dan sarung tangan perlu didaftarkan dengan MDA?
Ya, jika pengilang membuat tuntutan perubatan, contohnya untuk mencegah jangkitan penyakit atau untuk kegunaan pembedahan dan klinikal. Menurut MDA/GD/0033, pelitup muka perubatan ialah peranti Kelas A dan mesti memenuhi EN 14683:2019, ASTM F2100-19 atau YY/T 0969/0469. Sarung tangan pemeriksaan ialah Kelas A, manakala sarung tangan pembedahan ialah Kelas B dan perlu dinilai oleh CAB. MDA/GD/0058 menetapkan piawaian bagi gaun, coverall, apron, penutup kepala dan kasut, pelindung muka dan gogal. Walaupun Kelas A tidak memerlukan CAB, laporan ujian lengkap mesti dihantar kepada MDA. PPE untuk kegunaan industri tanpa tuntutan perubatan tidak dikawal oleh MDA. WhatsApp 010-206 2070.
Frequently asked questions
Do face masks need MDA registration in Malaysia?
Which standard does a surgical mask need to meet for MDA?
Are medical gloves Class A or Class B?
Does Class A PPE need test reports if there is no CAB assessment?
Is a KN94 or KN95 mask a medical device?
Who can register masks and PPE with MDA?
Registering masks, gloves or PPE?
Send us the product list, the claims on the label and the test reports you already have. We will check each item against MDA/GD/0033 and GD/0058, confirm the class, flag any missing tests, and file the registrations.