Published Jun 26, 2026 | 7:00 AM ⚊ Updated Jun 26, 2026 | 7:00 AM
To most people, every medical glove looks the same. Inside a hospital, they perform different jobs.
Synopsis: A Maharashtra FDA investigation into allegedly unsterilised surgical gloves reveals the hidden journey of one of healthcare’s most overlooked medical devices. Tracing the path from manufacturing and sterilisation to imports, procurement and regulation, the feature examines how India safeguards surgical gloves and what the case means for patient safety and medical device oversight.
The patient never sees it.
By the time anaesthesia takes effect, the operating theatre settles into a perfect, repeated choreography. Instruments are spread out orderly in trays, and a circulating nurse counts swabs. The scrub nurse tears open a paper packet and holds out a pair of surgical gloves. The surgeon slides one hand in, then the other, flexes the fingers and waits for the first incision.
It is a ritual repeated thousands of times every day across India.
Patients place trust in those gloves without ever asking where they came from, how they were made or who verified that they were safe. They trust that somewhere between a factory, a sterilisation unit, a warehouse, a procurement office and a hospital store, every process worked exactly as intended.
They trust one word printed on the packet. “Sterile”.
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The assumption came under scrutiny when the Maharashtra Food and Drug Administration raided a Palghar-based manufacturer after alleging that surgical gloves labelled as sterile had been supplied to government hospitals without undergoing proper sterilisation.
Officials seized stock worth more than ₹2 crore. The manufacturer attributed the issue to a malfunction in its sterilisation equipment and said it had initiated a recall after identifying the problem.
The case has since travelled beyond one factory.
It drew attention to a medical device that hospitals handle millions of times every year, yet remains invisible outside their walls. It has also exposed a supply chain that stretches from rubber plantations and manufacturing clusters in Malaysia and Thailand into Indian hospitals through procurement systems that few patients ever think about.
The Maharashtra case raises questions that reach further than the investigation itself. What makes a surgical glove sterile? Who certifies it? Can hospitals trace where it came from? And when something goes wrong, where in that chain does responsibility begin?
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To most people, every medical glove looks the same. Inside a hospital, they perform different jobs.
“There are two basic categories of medical gloves,” Manmohan Gulati, Secretary of the Indian Rubber Gloves Manufacturers Association(IRGMA), told South First. “One is the examination glove, and the other is the surgical glove.”
Examination gloves are used in outpatient departments, diagnostic laboratories, clinics and pharmacies while examining patients, drawing blood or administering injections. They provide a barrier between healthcare workers and patients but are supplied as non-sterile products because they do not enter surgical wounds.
Surgical gloves serve a different purpose.
“They are used by surgeons during operations, and these gloves have to be sterilised,” Gulati said. “Examination gloves are non-sterile, whereas surgical gloves used in operating theatres are sterilised.”
The distinction also determines how the products are regulated. Under India’s Medical Devices Rules, 2017, examination gloves fall under Class A, while sterile surgical gloves go under Class B because they contact sterile body tissue during invasive procedures.
The higher classification brings additional manufacturing, quality management and documentation requirements.
Sterility is not a marketing claim. It is the product of every step that follows.
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Long before a surgeon opens a packet, the glove begins its journey hundreds or thousands of kilometres away.
Gulati said the manufacturing process is designed to minimise human handling from the start.
Production lines stretch close to 100 metres. Ceramic hand moulds move continuously through chemical tanks where layers of natural latex or synthetic nitrile form, cure, wash and dry before the finished gloves strip from the moulds.
“When a glove is produced, it goes directly into a box,” Gulati explained. “If it is an examination glove, it is packed into an outer carton directly, and it is not sterilised.”
The journey of a surgical glove diverges here.
Instead of moving to dispatch, it enters a clean-room environment where workers carry out packaging under controlled conditions.
“The people packing and carrying out quality processes are dressed in proper PPE kits so that there is no contamination,” Gulati said.
The gloves move to sterilisation only after packaging.
“The purpose of sterilisation is to ensure that the gloves are free from viruses or microorganisms because these are the gloves a surgeon wears before operating on a patient.”
That sequence is designed to preserve sterility until the sealed packet opens inside the operating theatre. The Maharashtra investigation has raised questions about what happens when that sequence breaks.
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India regulates medical gloves through the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017.
Manufacturers must operate under quality management systems such as ISO 13485. Surgical gloves must comply with Bureau of Indian Standards specifications that test freedom from holes, tensile strength, dimensions, packaging integrity and sterility.
The government has also expanded its network of Medical Device Testing Laboratories to strengthen testing and surveillance across medical devices, including gloves.
The regulations describe how gloves should be manufactured, tested and marketed. The Maharashtra investigation has shifted attention to how consistently those requirements travel with a product once it enters supply chains, procurement agencies and hospital stores.
The story of many surgical gloves used in Indian hospitals begins far from India.
Malaysia and Thailand dominate the global rubber glove industry, supplying hospitals across North America, Europe, the Middle East and Asia. Malaysia spent decades building an industry around natural rubber, automation and manufacturing incentives.
Thailand followed, supported by one of the world’s largest natural rubber bases. An entire industrial ecosystem evolved: chemical processing, machinery, packaging, logistics, all oriented around medical gloves.
The COVID-19 pandemic accelerated their dominance. As global demand for personal protective equipment surged, manufacturers expanded capacity. The Malaysian Rubber Glove Manufacturers Association said its members continue supplying hundreds of billions of gloves annually and are investing in automation, digital traceability and international quality standards.
For India, that success created a dependency.
Hospitals opted for imported gloves while domestic manufacturers competed against suppliers whose industries had matured decades earlier.
The economics shifted further after the ASEAN-India Free Trade Agreement progressively reduced import duties on thousands of products, including medical gloves. Lower tariffs made imports from Malaysia and Thailand more competitive in the Indian market, particularly in government procurement, where pricing often determines who wins a tender.
For Indian manufacturers, the competition has become inseparable from the debate over regulation.
The Maharashtra investigation has revived concerns that Indian manufacturers said they have raised with regulators for years.
For Gulati, the debate is not about whether India should import gloves. It is about how they enter the country.
He argued that one of the biggest regulatory gaps lies in the import of gloves in bulk rather than in final dispenser-box packaging.
“The glove does not go into a gunny bag. Across the world, this is the process that is followed,” Gulati said. “But what is happening is that rejected gloves from manufacturers outside India are put into gunny bags, imported and repacked.”
He said some Indian importers source lower-grade gloves from Malaysia and Thailand for lower prices.
“They purchase these gloves at the cheapest possible rates because the manufacturers there have already classified them as B-grade gloves. These gloves cannot be sold in their own countries and cannot be exported through the normal supply chain.”
Once these products arrive in India, Gulati alleged, importers repackage them before supplying hospitals.
“The gloves pass through customs and are then taken to godowns where they are repacked. There is no traceability. You don’t know who manufactured the glove, what the batch number is or what standards were followed.”
He also said sterile surgical gloves should leave factories only after sterilisation and final packaging.
“I want to put this on record. Nowhere in the world can a sterile glove leave the factory without being sterilised and packed into its final carton.”
The CDSCO has not publicly confirmed these allegations. No regulatory finding has linked the Maharashtra investigation to imported gloves.
Malaysia’s glove industry disputes any suggestion that its manufacturing falls short. The Malaysian Rubber Glove Manufacturers Association said its members have built their reputation through investments in automation and adherence to global quality standards.
The association said its members work with ISO and ASTM International while expanding blockchain-based supply chain tools to strengthen transparency. It said Malaysia exports to some of the most demanding healthcare markets in the world, including the United States, Europe and Japan.
The contrast points to the challenge facing Indian regulators. If the same glove can travel thousands of kilometres before reaching an Indian hospital, how should regulators verify not only where it came from but whether every step, from manufacturing and sterilisation to transport and storage, met Indian requirements?
Every year, government hospitals purchase millions of gloves through competitive tenders. In many cases, price decides the winner.
Gulati recalled one case his association had documented. Without naming the institution, he said a government hospital in Delhi-NCR awarded a glove tender to a trader who did not own a manufacturing facility.
“When our representatives went there, there was no factory. There was just one person and a security guard.”
Gulati said the trader had uploaded a certificate on a government procurement portal before supplying gloves that did not match the tender specifications.
“The tender was for powder-free latex gloves. The gloves supplied were powdered gloves.”
The association said it has submitted documents relating to such cases to regulators for over four years.
“We have written more than 500 representations. We have provided evidence. We have shown warehouses where gloves were being repacked. There has been some progress, but not enough for such a critical medical device.”
These allegations have not been established through regulatory findings. They point to a policy question that regulators and procurement agencies have yet to resolve: how should public hospitals balance price with traceability, compliance and patient safety?
Following the Maharashtra case, the association renewed a representation to the CDSCO proposing five reforms.
It wants India to prohibit glove imports in bulk and allow imports only in final dispenser-box packaging, arguing this would improve traceability and reduce repackaging.
It has also proposed stricter enforcement of the Medical Devices Rules, requiring imported gloves to comply with Bureau of Indian Standards specifications before entering the market.
A third recommendation sought mandatory declarations from manufacturers and importers stating whether gloves are intended for medical or non-medical use.
To strengthen accountability, the association wants every dispenser box to display the name and contact details of the ISO 13485-certified manufacturer so that hospitals and regulators can identify the source of every product.
It has also called for a withdrawal of powdered gloves in line with international clinical practice.
“We’re not asking for major reforms,” Gulati said. “These are practical steps. If these five points are implemented, I believe 60% of the problem will be addressed.”
The Maharashtra investigation began with one manufacturer. It has since opened a conversation about something larger.
India wants to become a medical device manufacturing hub. It has introduced production-linked incentive schemes, strengthened regulation and encouraged domestic manufacturing across healthcare products.
Yet in surgical gloves, one of the most widely used devices in every hospital, the country continues to rely on imports from manufacturing centres in Southeast Asia.
The responsibility of regulators is not to decide whether a glove was manufactured in Kochi, Kuala Lumpur or Bangkok. Their responsibility is to ensure that every glove reaching an operating theatre meets the same standards of quality, sterility and traceability.
For patients, none of these debates is visible.
They do not see production lines stretching across factories in Malaysia. They do not see clean rooms where surgical gloves are packed. They do not see sterilisation chambers, customs clearances, procurement tenders or regulatory inspections.
They see a surgeon putting on a pair of gloves.
That moment lasts only a few seconds. The journey that made it possible may have taken weeks, crossed borders and passed through dozens of checkpoints before arriving inside an operating theatre.
Its larger legacy may be this: it has reminded regulators, manufacturers and hospitals that patient safety does not begin with the first incision.
It begins long before a surgeon reaches for a sealed packet carrying one word. Sterile.
(Edited by Majnu Babu)
