Other

Vulcanised rubber gloves, mittens and mitts (live working insulating, protective)

BIS QCO APPLICABLE · ISI MARK SCHEME · IS 13774 · CDSCO OVERLAY

HSN 4015 19 00 (vulcanised rubber gloves, mittens and mitts, other than surgical or medical examination) is covered by a Bureau of Indian Standards Quality Control Order. Conformity to IS 13774:2021 is mandatory under the ISI Mark Scheme with effect from 01 July 2024 (small enterprises from 01 October 2024; micro enterprises from 01 January 2025) under the Electrical Accessories (Quality Control) Order, 2023. Central Drugs Standard Control Organisation oversight applies as a separate customs-clearance overlay for surgical and medical examination gloves falling within this tariff line.

What this is

HSN code

4015 19 00

Chapter

40 · Rubber and articles thereof

BIS QCO

Applicable · ISI Mark Scheme · CM/L required

Indian Standard

IS 13774:2021 · effective 01-07-2024

Applicable Partner Government Agencies

BISBIS·Bureau of Indian Standards

CDSCOCDSCO·Central Drugs Standard Control Organisation

Compliance steps

1
Source only from a Bureau of Indian Standards CM/L-licensed manufacturer holding a current licence against IS 13774:2021 for live working gloves of insulating material. Verify the CM/L number, licensed product scope, and manufacturing facility on the BIS online register before placing the purchase order.
Electrical Accessories (Quality Control) Order, 2023 · S.O. 43(E) dated 01-01-2024
2
Confirm the applicable enforcement date for the supplier's enterprise category: 01 July 2024 for large enterprises, 01 October 2024 for small enterprises, and 01 January 2025 for micro enterprises. Shipments despatched before the relevant date for that enterprise size are not covered by the QCO.
S.O. 43(E) dated 01-01-2024 · Electrical Accessories (Quality Control) Order, 2023
3
Ensure every glove bears the ISI mark and the supplier's CM/L number in accordance with Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018. Marking must appear on the product itself and not on packaging alone.
Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018 · Electrical Accessories (Quality Control) Order, 2023
4
If the consignment includes surgical gloves (Class B medical device) or medical examination gloves (Class A medical device), ensure compliance with the Medical Devices Rules, 2017 as amended and arrange referral to the Assistant Drug Controller (I) office at the port. BIS QCO obligations under IS 13774:2021 are separate from and additional to the CDSCO medical device registration requirement.
G.S.R. 78(E) dated 31-01-2017 · S.O. 648(E) dated 11-02-2020 · G.S.R. 102(E) dated 11-02-2022 · CDSCO letter 29/Misc/03/2022-DC(273) dated 03-01-2023
5
Quote the supplier's BIS CM/L number on the bill of entry. Where surgical or medical examination gloves are declared, customs will refer the bill of entry to the Assistant Drug Controller (I) office; absent or expired CM/L or medical device registration triggers consignment detention.
BIS Act, 2016 · Customs Act, 1962 · Medical Devices Rules, 2017

A word of counsel

The single most consequential error on this tariff line is treating IS 13774:2021 as covering all vulcanised rubber gloves in HSN 4015 19 00. The QCO scope is specific to live working gloves of insulating material; protective gloves for firefighters fall under IS 16874:2018 under a separate Protective Textiles QCO (S.O. 1707(E)), and surgical or medical examination gloves attract CDSCO medical device registration entirely independent of the BIS ISI Mark obligation. An importer who presents a CM/L against IS 13774:2021 for a consignment of surgical gloves will face detention on the medical device compliance track regardless of BIS marking status.

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Frequently asked

Does HSN 4015 19 00 require BIS certification?

Yes, for live working gloves of insulating material. Conformity to IS 13774:2021 is mandatory under the ISI Mark Scheme from 01 July 2024 (large enterprises), 01 October 2024 (small enterprises), and 01 January 2025 (micro enterprises) under the Electrical Accessories (Quality Control) Order, 2023.

Are surgical gloves and medical examination gloves subject to additional requirements beyond BIS QCO?

Yes. Surgical gloves (Class B) and medical examination gloves (Class A) are medical devices regulated by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017. Bills of entry containing these products must be referred to the Assistant Drug Controller (I) office at the port.

Do the staggered enforcement dates under S.O. 43(E) affect all importers equally?

No. The enforcement date is 01 July 2024 for large enterprises, 01 October 2024 for small enterprises, and 01 January 2025 for micro enterprises; the BIS QCO obligation activates on the date applicable to the foreign manufacturer's enterprise classification.

Does a single CM/L licence against IS 13774:2021 cover all insulating glove voltage classes and manufacturing facilities?

No. The CM/L is scope-specific by voltage class, glove category, and licensed manufacturing facility; gloves of a different voltage rating or from an unlicensed plant are not covered under the same licence.

Last verified against gazette notifications: 2026-05-18. Source: BIS / CDSCO / Indian Customs CUSDATA.