Of a kind used for medical, surgical, dental or veterinary purposes

Vulcanised rubber gloves for medical, surgical, dental or veterinary use

HSN 4015 12 00 (vulcanised rubber gloves for medical, surgical, dental or veterinary purposes) is subject to Central Drugs Standard Control Organisation (CDSCO) import compliance under the Medical Devices Rules, 2017, as amended. Surgical gloves are classified as Class B medical devices and medical examination gloves as Class A; all bills of entry must be referred to the Assistant Drug Controller (I) office for verification of compliance.

1. 1
   Ensure the foreign manufacturer and the importer hold valid registrations under the Medical Devices Rules, 2017, as amended, covering the relevant device class — Class B for surgical gloves and Class A for medical examination gloves. Compliance must be established before filing the bill of entry.
   Medical Devices Rules, 2017 · 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
2. 2
   Ensure the bill of entry is routed to the Assistant Drug Controller (I) office for mandatory verification of Medical Devices Rules, 2017 compliance before out-of-charge. This referral requirement applies to all bills of entry containing surgical gloves and medical examination gloves without exception.
   Letter No. 29/Misc/03/2022-DC(273) dated 03-01-2023 issued by Drug Controller General (I), CDSCO, New Delhi