PharmShield Pro Nitrile — Nitrosamine-Controlled Sterile
Latex-Free Nitrile · Low-Nitrosatable Formulation · Gamma Sterile (STERILE R)
PharmShield Pro Nitrosamine-Controlled Sterile Nitrile Gloves are purpose-built for elevated pharmaceutical and biopharma cleanliness requirements. Manufactured using a specially controlled low-nitrosatable nitrile formulation and optimised processing technology, the gloves are designed to minimise nitrosamine formation and process-related chemical residues — a growing regulatory concern under FDA, EMA, and ICH M7 guidance. Latex-free, validated to SAL 10⁻⁶ in both ETO and Gamma variants.
Engineered for performance. Verified at every step.
The engineering principles that define every PharmShield glove — from material chemistry to packaging integrity.
Nitrosamine-Controlled Formulation
Manufactured using a specially controlled low-nitrosatable nitrile formulation designed to minimise nitrosamine formation and reduce process-related chemical residues — directly addressing FDA, EMA, and ICH M7 regulatory requirements for nitrosamine risk assessment in pharmaceutical manufacturing.
100% Latex-Free Protection
Produced from synthetic nitrile butadiene rubber (NBR), completely eliminating the risk of Type I natural rubber latex allergies — making these gloves a safe choice for operators and sensitive patient-contact environments.
Enhanced Chemical Cleanliness Profile
Optimised manufacturing and post-processing controls support a low extractable and low residue glove performance — providing quality teams with greater confidence during product contact risk assessments, technical audits, and regulatory submissions under FDA, EU MDR, and ICH scrutiny.
Validated Sterility Assurance (SAL 10⁻⁶)
Available in ETO and Gamma irradiation sterilised variants, validated to a Sterility Assurance Level of 10⁻⁶ — ensuring microbial safety for critical aseptic and sterile processing operations.
Industry-Leading AQL 0.65
Manufactured under stringent quality controls ensuring superior barrier integrity and dependable resistance against pinholes and critical defects.
Superior Puncture & Tear Resistance
Advanced nitrile formulation delivers excellent puncture resistance, tear strength, and durability — providing dependable barrier integrity during extended cleanroom and aseptic operations.
Enhanced Tactile Sensitivity
Thin, lightweight nitrile construction delivers excellent fingertip sensitivity and precise handling control — supporting accuracy during critical aseptic manipulations and precision handling tasks.
Low Particulate & Powder-Free Design
Cleanroom-oriented powder-free construction minimises particulate contribution and supports compatibility with ISO 4–7 classified environments.
Broad Application Versatility
Suitable for pharmaceutical aseptic processing, vaccine manufacturing, injectable drug production, cell and gene therapy, sterile compounding, biotechnology, and medical device manufacturing.
Built to the global standards your industry demands.
Independently certified, batch-traceable, and validated against the regulatory frameworks that govern pharmaceutical, biopharma and food-contact use.
Quality Management
01- check_circleISO 13485:2016
- check_circleISO 9001:2015
Performance & Defect Control
02- check_circleAQL 0.65
- check_circleEN 374 Type B
- check_circleASTM D 6319
- check_circleIS 15354
- check_circleISO 11193
Biocompatibility
03- check_circleISO 10993 Part 1
- check_circlePart 5
- check_circlePart 10
- check_circlePart 11
- check_circlePart 23
Sterility Validation
04- check_circleSAL 10⁻⁶
- check_circleISO 11737-1
- check_circleISO 11737-2
Regulatory Alignment
05- check_circleFDA Nitrosamine Guidance
- check_circleEMA Nitrosamine Risk
- check_circleICH M7
Food-Contact Compliance
06- check_circleUS-FDA-177-2600
Every detail, on the record.
Trusted across the industries where precision is non-negotiable.
Explore the range.
PharmShield Pro Latex — Nitrosamine-Controlled Sterile
Powder-Free Natural Rubber Latex · Low-Nitrosatable Formulation · Gamma Sterile (STERILE R)
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PharmShield Pro Nitrile — Anti-Static Sterile
Latex-Free Nitrile · ESD-Dissipative Formulation · Gamma Sterile (STERILE R)
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PharmShield Pro Nitrile — Vacuum Packed Sterile
Latex-Free Nitrile (NBR) · Single Vacuum Pack · Gamma Sterile (STERILE R) · SAL 10⁻⁶
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