Voluntary BIS Standards

ISI Mark for Disposable Surgical Rubber Gloves – IS 13422

Medical device since 2017Medical Devices & Textiles

BIS ISI mark (Scheme-I)

IS 13422

Minimum marking fee per year: ₹14,000 – ₹70,000; Micro to large firms
Testing cost: ₹7,650 – ₹15,000; Based on 4 lab prices
HSN code: 40151100; Check the code with customs

CDSCO, the Indian regulator for medical devices, controls Disposable Surgical Rubber Gloves (IS 13422) under the Medical Devices Rules, 2017. The ISI mark is optional. You can get it to show that your product meets the Indian Standard.

How it works: a BIS-approved lab tests your samples against IS 13422. A BIS officer then visits your factory. If everything is in order, BIS gives you a licence. You can then print the ISI mark with your licence number (CM/L number). Factories outside India apply under the Foreign Manufacturers Certification Scheme (FMCS). They must also name a representative in India, called an Authorised Indian Representative (AIR).

Every year you pay BIS a minimum marking fee. It is ₹14,000 for micro firms and ₹70,000 for large firms. The fee also depends on how much you make: ₹1.74 per 100 pairs. You pay whichever amount is higher. Lab testing costs about ₹7,650 – ₹15,000 per sample, based on quotes from 4 BIS-approved labs. These prices are a guide only and do not include GST.

Indian Standard covered

IS number	Product	Testing cost
IS 13422	Disposable Surgical Rubber Gloves	₹7,650 – ₹15,0004 labs

Legal order: Licensing under CDSCO Medical Device Rules, 2017; BIS ISI voluntary/parallel

Minimum marking fee by firm size

You pay BIS a minimum marking fee every year. Micro, small and medium firms (with Udyam registration) pay less. BIS also works out a fee from the unit rate and your production. You pay whichever amount is higher.

Large firms: ₹70,000
Medium firms: ₹56,000
Small firms: ₹35,000
Micro firms: ₹14,000

Unit rate: ₹1.74 per 100 pairs

Other BIS charges: ₹9,000 for every ISI mark product: application charge ₹1,000 · licence fee ₹1,000 · audit charges ₹7,000
Foreign manufacturers: Get a detailed quote
Our consulting fee: Best-value quote – let’s talk

All prices are a guide only and do not include GST. Rules and dates can change, so check the latest notice before you apply. Ask us for an up-to-date quote.

Common questions

Is BIS certification mandatory for Disposable Surgical Rubber Gloves?

Not from BIS. CDSCO controls this product under the Medical Devices Rules. The ISI mark is optional, but it helps to show quality.

What is the BIS marking fee for Disposable Surgical Rubber Gloves?

The minimum fee each year is ₹70,000 for large firms, ₹56,000 for medium firms, ₹35,000 for small firms and ₹14,000 for micro firms. Your firm size comes from your Udyam registration. BIS also works out a fee at ₹1.74 per 100 pairs. You pay the higher amount. GST is extra. These figures are a guide, based on the BIS fee list.

How much does testing for IS 13422 cost?

Lab charges are usually ₹7,650 – ₹15,000 per sample. This is based on quotes from 4 BIS-approved labs. The final price depends on your model, its versions and the tests needed.

What is the HSN code for Disposable Surgical Rubber Gloves?

It usually comes under HSN 40151100. Check the code on your bill of entry, because customs decides the code for the exact product.

Can a foreign manufacturer get the ISI mark?

Yes. Factories outside India apply under the Foreign Manufacturers Certification Scheme (FMCS). They must also name a representative in India, called an Authorised Indian Representative (AIR). The licence is in the name of the factory. Once the product is mandatory, importers cannot clear the goods at customs without it.

How long does BIS certification take?

Factories in India usually get a licence 30 to 60 days after a good test report. Factories outside India (FMCS) should plan for four to six months, including the factory visit.

See all 1,071 in Voluntary BIS Standards

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