PharmShield Pro Latex — Nitrosamine-Controlled Sterile
Powder-Free Natural Rubber Latex · Low-Nitrosatable Formulation · Gamma Sterile (STERILE R)
PharmShield Pro Nitrosamine-Controlled Sterile Latex Long Gloves are engineered for highly critical pharmaceutical, biopharma, cleanroom, and contamination-sensitive environments. Manufactured using a specially controlled low-nitrosatable formulation and optimised processing technology, the gloves are designed to minimise nitrosamine formation and process-related chemical residues — supporting enhanced chemical cleanliness and aligned with FDA, EMA, and ICH M7 regulatory guidance.
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 formulation and optimised processing technology, designed to minimise nitrosamine formation and reduce process-related chemical residues — supporting enhanced chemical cleanliness for sensitive aseptic and pharmaceutical operations.
Validated Sterility Assurance (SAL 10⁻⁶)
Sterilised using Gamma irradiation or ETO and validated to a Sterility Assurance Level of 10⁻⁶ for critical aseptic applications.
Enhanced Chemical Cleanliness Profile
Controlled manufacturing and post-processing systems support a low extractable and low residue profile — giving pharmaceutical and biopharma quality teams greater confidence during audits, technical reviews, and regulatory submissions under FDA, EU MDR, and ICH scrutiny.
Industry-Leading AQL 0.65
Manufactured under stringent quality controls to ensure superior barrier integrity and dependable resistance against pinholes and critical defects.
100% Individual Quality Control
Every glove undergoes rigorous inspection to ensure consistent quality, cleanliness, and dependable performance in highly regulated environments.
Advanced Double-Chlorination Technology
Supports smooth donning, reduced surface tackiness, and controlled glove-to-glove interaction — maintaining excellent grip and tactile sensitivity throughout extended use.
Superior Form-Fitting Comfort
Premium natural rubber latex delivers exceptional elasticity and anatomical fit, reducing hand fatigue during prolonged precision operations.
Sterile Individual Packaging
Each pair is individually packed under controlled cleanroom conditions to support sterility maintenance, full lot traceability, contamination-controlled transfer, and efficient introduction into ISO-classified environments.
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 3578
- 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 Nitrile — Nitrosamine-Controlled Sterile
Latex-Free Nitrile · Low-Nitrosatable Formulation · Gamma Sterile (STERILE R)
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PharmShield Pro Latex — Vacuum Packed Sterile
Powder-Free Natural Rubber Latex · Vacuum Pack · Gamma Sterile (STERILE R) · SAL 10⁻⁶
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PharmShield Latex — Individually Packed ETO Sterile
Powder-Free Natural Rubber Latex · ETO Sterile · SAL 10⁻⁶ · Individual sterile pouch
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