Surgical gloves and gowns in Saudi Arabia are the sterile gloves and barrier gowns used in operating theatres, alongside examination gloves and isolation gowns for wards. This page lists Saudi suppliers and sets out what SFDA expects: the recognised glove standards in guidance MDS-G004, gown classes under EN 13795 and AAMI PB70, storage across long hot distances, and NUPCO tender points.
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In Saudi Arabia, surgical gloves and gowns are the sterile barrier products worn by theatre teams, bought together with examination gloves and isolation gowns for wards, emergency departments and primary care centres. They belong to the medical consumables family in Saudi Arabia, which explains SFDA import rules and NUPCO tendering at family level; here the focus is the product specification SFDA and hospitals check.
| Product | Where it is used | Specification points for a Saudi tender |
|---|---|---|
| Sterile rubber surgical gloves | Operating theatres, cath labs, obstetrics | ISO 10282, EN 455 test reports, latex or synthetic, powder-free, half sizes |
| Synthetic surgical gloves | Latex-safe theatres and allergic staff | Polyisoprene or neoprene, accelerator-free option, chemotherapy test data |
| Latex examination gloves | Wards, clinics, dental | ISO 11193-1, AQL, box count |
| PVC (vinyl) examination gloves | Short, low-risk tasks | ISO 11193-2, length, AQL |
| Nitrile examination gloves | Wards, labs, pharmacy | EN 455 test reports, thickness, chemical resistance claims |
| Surgical gowns | Theatres, day surgery | EN 13795-1 standard or high performance, reinforced zones, sterile pack |
| Isolation gowns | Isolation rooms, infection control | AAMI PB70 level, closures, cuffs |
Gowns and gloves are also supplied inside custom procedure packs with drapes, which fall under disposable medical supplies in Saudi Arabia. Buyers who need work gloves for plants, refineries or construction should use the industrial safety gloves page; those are PPE and are not accepted as medical gloves.
SFDA guidance MDS-G004 (version 1.1, December 2022) lists the recognised standards that glove makers can use to prove the Essential Principles of Safety and Performance when applying for Medical Device Marketing Authorization under MDS-REQ 1. As of 2026, check the SFDA site for any later version before a submission.
| Recognised standard (per MDS-G004) | Covers | Applies to |
|---|---|---|
| SFDA.MD/ISO 10282:2022 | Single-use sterile rubber surgical gloves, specification | Surgical gloves |
| SFDA.MD/ISO 11193-1:2022 | Examination gloves of rubber latex or rubber solution | Latex examination gloves |
| SFDA.MD/ISO 11193-2:2022 | Examination gloves of poly(vinyl chloride) | Vinyl examination gloves |
| EN 455-1:2020+A1:2022 | Freedom from holes | All medical gloves |
| GSO EN 455-2:2022 | Physical properties | All medical gloves |
| EN 455-3:2015 | Biological evaluation | All medical gloves |
| EN 455-4:2009 | Shelf life determination | All medical gloves |
Two points in MDS-G004 matter to buyers. All requirements and test methods in a standard cited in the application must be met, or SFDA must be given a justification; and labelling must meet both the standard and MDS-REQ 1. In practice, ask the supplier for the full test reports against each standard, not only a certificate.
The pinhole figure in EN 455-1 is the one to check first: SATRA reports AQL 0.65 for surgical gloves and AQL 1.5 for examination gloves in the 2020 edition. Oncology and pharmacy buyers also ask for testing to ASTM D6978 against chemotherapy drugs.
Gowns are rated by tested barrier performance. EN 13795-1 has standard and high performance classes and treats the front and sleeves as critical zones; the MSF catalogue summary of the 2019 edition gives at least 20 cm water pressure in the critical zone for standard performance gowns and at least 100 cm for high performance. ANSI/AAMI PB70 uses Levels 1 to 4, and only Level 4 passes the synthetic blood and viral tests of ASTM F1670 and ASTM F1671.
Choose by procedure: long, high-fluid cases in orthopaedics, obstetrics and trauma call for high performance or Level 4 reinforced gowns, while short dry procedures can use standard gowns at lower cost.
Rubber gloves age faster in heat, and a consignment travelling from a Riyadh or Dammam warehouse to hospitals in the south or north can spend many hours on the road in summer. Keep gloves within label temperatures throughout, and use the shelf life rules for imports explained on the family page.
Government hospitals receive most volume through NUPCO tenders, and private groups buy from authorised distributors on annual agreements. In both routes the supplier must hold SFDA marketing authorisation for each glove and gown, and a licensed warehouse.
Brands on ListGCC include Ansell, maker of GAMMEX sterile surgical gloves in latex and synthetic grades, AMMEX, which makes medical examination gloves, and Safecare, which makes nitrile examination gloves and isolation gowns.
Material, performance level, pack format and registration drive price. Synthetic surgical gloves cost more than latex, reinforced and Level 4 gowns more than standard ones, and gowns in custom packs depend on every other component in the pack. Sea freight lands at Jeddah Islamic Port or King Abdulaziz Port in Dammam; a new brand needs SFDA marketing authorisation before the first shipment, which adds months.
The same suppliers often quote syringes and hypodermic needles and dressings and wound care. To reach several of them, post your requirement with sizes, standards and volumes.