Pharma-Grade Gloves

Manufactured to the Standards Your Industry Demands

From sterile production lines to analytical labs, Sri Anusham has supplied examination long cuff gloves to pharmaceutical and biotech companies for over 10 years. 100% made in India for reliable, uninterrupted supply.

ISO 13485:2016
ISO 9001:2015
EN 374 Type B
ISO 10993
CDSCO Certified
ISO 11193
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Built for Pharma-Grade Manufacturing

Our state-of-the-art manufacturing facility, quality systems, and documentation processes are built for the stringent requirements of pharmaceutical and biotech companies.

GMP-Compliant, In-House Manufacturing

  • 100% in-house manufacturing — no outsourced steps, no supply chain risk
  • Fully automated production units delivering consistent output and batch-to-batch uniformity
  • End-to-end in-house production from raw materials to final dispatch with 13 QA checks ensuring consistent quality
  • In-house QA lab with continuous testing throughout the manufacturing process

Global Certifications

  • ISO 13485:2016 & ISO 9001:2015 certified QMS — the quality management framework required by pharmaceutical suppliers
  • Compliance with ASTM D 3578, ASTM D 6319, IS 15354
  • Performance and safety testing includes biocompatibility (ISO 10993) and chemical resistance (EN 374)
  • Tested for compliance with US FDA 21 CFR 177.2600 for food contact applications

End-to-End Documentation Support

  • Certificate of Analysis (CoA) / Certificate of Conformance (CoC) per batch
  • Material Safety Data Sheet (MSDS) and Technical Data Sheet (TDS)
  • Equipment calibration records and Master List of SOPs
  • Easy vendor qualification support — ready to facilitate customer audits

Our Pharma & Biotech Glove Portfolio

Two core materials. Multiple sterility and packaging configurations. Every variant engineered for the controlled environments of pharma and biotech manufacturing.

PharmShield Nitrile Gloves – Powder-Free

Best for: Chemical handling, API manufacturing, lab work, food handling, latex-allergy-sensitive environments

EN 374 Type B chemical resistance — certified barrier against industrial chemicals and solvents

100% latex-free and protein-free — eliminates Type-I allergy risk and contamination risk

Advanced double-chlorination — smooth donning, efficient double-donning for high-risk protocols

Superior puncture resistance compared to natural rubber latex

FDA 21 CFR 177.2600 compliant — dual-use for food-contact and pharma applications

Nitrosamine-free & anti-static variants available on request

  • AQL 0.65
  • Sterile ETO / Gamma
  • SAL 10⁻⁶
  • Length 240–600 mm
  • Non-Sterile available
  • EN 374 Type B
  • ASTM D 6319
  • IS 15354
PharmShield Latex Examination Gloves Gamma Sterile Version 1

PharmShield Latex Examination Gloves

Best for: Precision handling, QC labs, formulation areas requiring high tactile sensitivity, food handling

Superior elasticity and tactile sensitivity — preferred for precision handling of tablets, capsules, and delicate formulations

Advanced double-chlorination — effortless donning and efficient double-gloving protocols

EN 374 Type B chemical resistance certified

FDA 21 CFR 177.2600 compliant for food contact applications

AQL 0.65 — 100% individual quality inspection before packaging

  • AQL 0.65
  • Sterile ETO / Gamma
  • SAL 10⁻⁶
  • Length 240–600 mm
  • Non-Sterile available
  • EN 374 Type B
  • ASTM D 3578
  • IS 15354

Certifications, Testing & Documentation That Stand Up to Audit

We know that in pharma procurement, trust is built on documentation. Here is the compliance infrastructure behind every glove we ship.

Quality System Certifications

ISO 13485:2016
ISO 9001:2015
CDSCO Certified

Product Performance Standards

ASTM D 6319
ASTM D 3578
EN 455 Parts 1–4
IS 15354
ISO 11193
EN 374 Type B
ISO 10993 Parts 1, 5, 10, 11 & 23
EN ISO 16523-1
ISO 11737-1 & 2
EN ISO 15223-1
EN 1041

End to End Document Support

Certificate of Analysis (CoA) per batch
Certificate of Conformance (CoC) per batch
Material Safety Data Sheet (MSDS)
Technical Data Sheet (TDS)
Equipment Calibration Records
Master List of SOPs
Vendor Qualification Pack
Audit-Ready Documentation System

Pharma Procurement Questions, Answered Directly

Common questions from quality managers and procurement teams in pharma and biotech.

Every shipment comes with a Certificate of Analysis (CoA) and Certificate of Conformance (CoC) per batch. Additional documentation available includes an MSDS, TDS, equipment calibration records, and a Master List of SOPs. Our centralised QA documentation system ensures fast access to compliance records for any customer query or audit.

Our PharmShield examination gloves comply with ISO 13485:2016, ISO 9001:2015, CE PPE 2016/425 Type B compliance, EN 455 Parts 1–4, EN 374 (chemical resistance), ISO 10993 (biocompatibility), ISO 11193, and ASTM D3578 (Latex) / ASTM D6319 (Nitrile). The facility is CDSCO-certified and compliant with BIS (IS 13422) and FDA requirements. Sterile variants are validated to ISO 11737-1 & 2 with a 10⁻⁶ SAL.

Yes. PharmShield Nitrile and Latex Gloves are EN 374 Type B certified, providing a verified barrier against a wide range of industrial chemicals and solvents. Detailed permeation data per EN ISO 16523-1 is available to support your process risk assessment.

Both our nitrile and latex PharmShield examination gloves are available in Non-Sterile, ETO (Ethylene Oxide), and Gamma Irradiation Sterile variants. Sterile gloves achieve a Sterility Assurance Level (SAL) of 10⁻⁶ and are validated per ISO 11737-1 & 2. Packaging options include dispenser box, individual pack, vacuum pack, and triple vacuum pack.

Yes. We provide complete registration packs and documentation to streamline your vendor approval process. Our centralised QA documentation system ensures fast access to compliance records for customer queries. As a 100% in-house manufacturer operating for over 35 years, we offer the supply reliability and documentation depth that pharma procurement teams require. We are also ready to facilitate customer audits.

Need Gloves for Your Pharmaceutical Manufacturing Facility?

Contact us to request samples or get expert recommendations for your specific pharmaceutical and biotech needs.

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