Pharmaceutical & Cleanroom Gloves for GMP Manufacturing
PharmShield pharmaceutical gloves are sterile and non-sterile nitrile and latex gloves built for GMP manufacturing, fill-finish and cleanroom environments — nitrosamine-controlled and accelerator-free options, gamma-sterile, vacuum-packed, ISO 13485 and EN 455 compliant, AQL 0.65 and fully batch-traceable. These are specialty pharma-grade and cleanroom gloves for regulated production lines, not generic consumer gloves — available with an extended ~300 mm cuff for fill-finish and splash-risk handling.
What Pharma Manufacturing Requires — and How PharmShield Delivers
ISO 13485:2016 Certified Quality System
Every PharmShield glove is manufactured within a globally recognized medical device quality management system, audited annually to ensure consistent quality, traceability, and regulatory compliance for pharmaceutical and critical applications.
Cleanroom Gloves for Pharmaceutical Manufacturing
Cleanroom gloves and cleanroom nitrile gloves for pharmaceutical manufacturing — low-particulate, powder-free and vacuum-packed for controlled environments, backed by validated sterilization and batch-level traceability. We confirm the cleanroom class and sterility grade your process actually requires rather than overstate it.
- check_circleTriple vacuum packing for controlled environments
- check_circleDouble/triple packaging for aseptic donning protocols
- check_circleETO and Gamma sterilized variants validated to SAL 10⁻⁶
- check_circleLow-particulate, powder-free; particle count data per batch
- check_circleNitrosamine-controlled & accelerator-free Pro options available
- check_circleExtended ~300 mm cuff option (vs standard ~240 mm) for forearm coverage
Available Documentation
COA and TDS available per batch. All documentation organised and dispatched consistently.
In pharmaceutical manufacturing, glove failure isn't just a safety issue — it's a batch-ending event. PharmShield's consistency across thousands of boxes is why we switched.
Quality Assurance Standard
Based on Pharma Industry Requirements
Products Built for You
Can't find the exact spec you need?
PharmShield has a full in-house R&D, validation, and documentation team. If your facility requires something beyond our standard range, we offer two pathways:
Option 1 — Product Duplication
Provide an existing product from any supplier. PharmShield will analyse and duplicate it to the same specification.
Option 2 — Spec Matching
Provide your specification requirements. PharmShield will formulate, prototype, validate, and supply to that spec.
Pharmaceutical Gloves — FAQ
Pharmaceutical manufacturing uses sterile and non-sterile nitrile and latex gloves that are powder-free, AQL 0.65 and batch-traceable. PharmShield pharmaceutical gloves are manufactured under an ISO 13485 quality system and comply with EN 455, with gamma- or ETO-sterile options for aseptic work and non-sterile dispenser packs for general production areas.
Yes. PharmShield gloves are made under GMP-controlled, ISO 13485-certified quality systems with AQL 0.65 sampling, 100% visual inspection and full batch-level traceability. A Certificate of Analysis (COA) and technical data sheet are issued per batch to support your QA file and customer audits.
A cleanroom glove is a low-particulate, powder-free glove — typically vacuum-packed and often sterile — designed to minimise contamination in controlled environments. We match the packaging and sterility to your cleanroom protocol and will confirm the specific class and particulate data we can support for your application rather than overstate it. Particle-count data is available per batch.
Yes. Nitrosamine-controlled and accelerator-free options are available in our PharmShield Pro range for facilities with chemical-cleanliness requirements or staff sensitive to Type IV accelerator allergens. If nitrosamine control is a concern for your process, ask for the Pro specifications. See the nitrile range →
Use sterile gloves (gamma or ETO, validated to SAL 10⁻⁶) for aseptic fill-finish and other operations that require a sterile barrier. Non-sterile powder-free gloves are appropriate for general manufacturing, weighing and packaging areas where a validated sterile barrier isn't required. Many facilities stock both and match the glove to the process step.
Standard pharmaceutical gloves run roughly 240 mm in length. PharmShield also offers an extended ~300 mm cuff option for added forearm coverage during fill-finish, pouring and splash-risk handling. Extended cuffs matter most where you need overlap with a gown sleeve in aseptic or chemical-handling work.
How We Serve Your Industry
Consultation
Needs analysis and regulatory requirement mapping
Sample Testing
On-site evaluation with your QA team
Customisation
Specification matching and formulation
Certification
Full documentation and compliance package
Supply Partnership
Ongoing supply with batch-level traceability
Consultation
Needs analysis and regulatory requirement mapping
Sample Testing
On-site evaluation with your QA team
Customisation
Specification matching and formulation
Certification
Full documentation and compliance package
Supply Partnership
Ongoing supply with batch-level traceability
Ready to Upgrade Your Pharma Glove Supply?
PharmShield has a full in-house R&D, validation, and documentation team. If your facility requires something beyond our standard range, we'll build it for you.