Swear Healthcare | Our Certifications

Our Certifications

Swear Healthcare Pvt. Ltd. operates under a rigorous framework of national and international regulatory approvals. Every glove we manufacture is backed by documented quality systems, government registrations, and third-party certifications — so that hospitals, surgeons, and healthcare workers can trust what they wear.

Quality management / ISO 13485

ISO 13485 is the internationally recognised standard for quality management systems in the medical device industry. It sets the requirements for how a manufacturer must plan, document, and control every step of production — from raw material sourcing to finished product dispatch.

International standard — QMS for medical devices

ISO 13485:2016

Swear Healthcare's entire manufacturing operation conforms to ISO 13485:2016. This means our facility, processes, and documentation meet the global benchmark for medical device quality systems. The certification covers our latex surgical gloves, latex examination gloves, and nitrile examination gloves.

Design control Process validation Post-market surveillance

Assurance of consistent, traceable quality

What this means for buyers

Every batch of gloves produced at our Dholpur facility is manufactured under a documented quality management system. This ensures traceability of materials, consistency in production, and a formal complaint-handling process. Government institutions and hospitals purchasing from Swear Healthcare can rely on audit-ready documentation at every stage.

Batch traceability Audit-ready records

International regulatory approvals

EU Medical Device Regulation (EU MDR)

EU CE marking / CE Mark — European conformity

The CE (Conformité Européenne) mark certifies that Swear Healthcare's medical gloves meet the health, safety, and environmental protection standards required to be sold in the European Economic Area. For an Indian manufacturer, holding CE certification signals a level of quality that goes well beyond domestic requirements.

Our gloves carry the CE mark, indicating full compliance with European medical device regulations. This involves independent assessment of product safety, performance, and clinical data by a recognised Notified Body. The CE mark is required by European hospitals and distributors and demonstrates our commitment to globally benchmarked safety standards.

EU MDR compliant Notified body assessed Export-ready

Issued by CDSCO / DCGI

Free Sale Certificate (FSC)

The Free Sale Certificate is an official document issued by India's Central Drugs Standard Control Organisation (CDSCO) confirming that Swear Healthcare's products are legally manufactured, registered, and freely sold in India. This certificate is a standard requirement when exporting medical devices to international markets and government procurement programmes.

CDSCO issued Export compliance

Indian regulatory compliance

Medical Device Rules, 2017

CDSCO registration

Under India's Medical Device Rules, 2017, all medical gloves must be registered with the Central Drugs Standard Control Organisation (CDSCO), which functions under the Ministry of Health & Family Welfare. CDSCO is India's equivalent of the US FDA for medical devices. Our products are duly registered and compliant.

Form MD-5 — Medical Device Rules, 2017

CDSCO manufacturing license

Swear Healthcare holds a valid CDSCO manufacturing license for medical gloves under the Medical Devices Rules, 2017. This licence authorises us to legally manufacture and supply medical gloves — including sterile latex surgical gloves (Class B) and latex/nitrile examination gloves (Class A) — across India, including to government hospitals and State Health Corporations.

Class A — examination gloves Class B — surgical gloves

Bureau of Indian Standards

BIS compliance — IS 4148 & IS 13422

Our surgical and examination gloves are manufactured in conformance with the relevant Bureau of Indian Standards (BIS) specifications — IS 4148 for surgical rubber gloves and IS 13422 for disposable surgical rubber gloves. These standards define material properties, dimensional requirements, tensile strength, elongation, and freedom from holes, ensuring every pair meets the safety requirements set by India's national standards body.

IS 4148 — surgical gloves IS 13422 — disposable surgical gloves

Business registrations

Swear Healthcare is a fully registered legal entity with all the statutory compliances required for manufacturing and supplying medical devices in India.

Ministry of MSME, Government of India

MSME registration

Swear Healthcare is registered as a Micro, Small & Medium Enterprise (MSME) under the Udyam Registration framework of the Ministry of MSME, Government of India. This registration recognises our manufacturing unit in Dholpur, Rajasthan and makes us eligible for government procurement preferences, priority sector treatment, and MSME-specific tenders issued by State Health Corporations and public hospitals.

Udyam registered Government procurement eligible Dholpur, Rajasthan

Goods & Services Tax, Government of India

GST registration

Swear Healthcare holds a valid GST registration, enabling us to issue tax-compliant invoices to all categories of institutional buyers — including government hospitals, State Health Corporations, distributors, and private healthcare chains. All our supply transactions are fully GST-compliant under the applicable HSN code for medical gloves.

GST compliant Tax invoice issued

Registered under the Companies Act, 2013

Company incorporation

Swear Healthcare Private Limited is incorporated as a private limited company under the Companies Act, 2013 and registered with the Registrar of Companies (RoC). The company operates out of Dholpur, Rajasthan, with its manufacturing facility and registered office in the same location. A Certificate of Incorporation is available on request for all institutional buyers and government procurement officers.

Private limited company RoC registered

Rajasthan State Drug Controller

Drug license — State Licensing Authority

As a manufacturer of medical devices in Rajasthan, Swear Healthcare holds a valid manufacturing drug license issued by the State Licensing Authority under the Drugs and Cosmetics Act. This license is required for the manufacture, sale, and distribution of medical gloves and is renewed periodically in compliance with state drug control regulations.

State drug license Rajasthan SLA

Product testing & standards

Beyond certifications, our gloves undergo rigorous physical and chemical testing before leaving our facility. These tests are conducted in accordance with Indian and international standards and are available as third-party lab reports on request.

Batch-level quality testing

Physical & mechanical testing

Every batch is tested for puncture resistance, tensile strength, and elongation at break — the three most critical parameters for surgical and examination gloves. Dimensional conformance (length, width, thickness) is also verified to ensure consistency across sizes. Freedom-from-holes testing (water leak test and air inflation test) is conducted on every production lot.

Puncture resistance Tensile strength Elongation at break Leak test

ISO 10993 framework

Biocompatibility & chemical safety

Our latex surgical and examination gloves are evaluated for biocompatibility, protein content, and residual chemical levels in accordance with international safety guidelines. Nitrile gloves are tested for accelerator chemical content and are available in formulations suitable for users with latex sensitivity. All product compositions are disclosed in our technical documentation.

Biocompatibility tested Protein content verified Chemical residue tested

Government supply eligibility

Swear Healthcare is a preferred supplier to State Health Corporations and government hospitals across India. Our complete certification profile ensures we meet all eligibility criteria under government tender norms.

State Health Corporation tenders

Tender eligibility — government hospitals

Our CDSCO registration, MSME status, ISO 13485 certification, and BIS compliance collectively satisfy the technical qualification criteria specified in most State Health Corporation and government hospital tenders. We have an established track record of supplying directly to government institutions across multiple states, with full documentation and audit trails available.

MSME procurement preference

Public Procurement Policy for MSMEs

Under the Public Procurement Policy for Micro and Small Enterprises, government buyers are mandated to procure a minimum percentage of their requirement from MSME suppliers. As a registered MSME manufacturer, Swear Healthcare qualifies for this preference, giving government institutions a policy-backed reason to choose us as a supply partner.