BIS Quality Control Order for Medical and Surgical Gloves (Single use medical examination gloves)

Conformity Assessment & Regulatory Compliance

Date: 21st February 2025 Place: New Delhi

Dear Reader,

Important update regarding Indian Standard applicable to all existing Licence holders/ New applicants/ manufacturers/ importers/ product sellers for the Medical and Surgical Gloves (Quality Control) Order, 2025.

BIS Quality Control Order for Medical and Surgical Gloves
(Single use medical examination gloves)

OVERVIEW

The Ministry of Chemicals and Fertilizers has issued a draft notification, known as the Medical and Surgical Gloves (Quality Control) Order, 2025. This order is proposed to take effect six months after its notification in the E-Gazette. Stakeholders are encouraged to submit their comments within 60 days of the notification.

Under this order, Medical and Surgical Gloves must adhere to the relevant Indian Standard IS 15354 (Part1): 2023 (Single use medical examination gloves (Part 1 Specification for gloves made from rubber latex or rubber solution)). and carry the Standard Mark, issued under a license from the Bureau of Indian Standards (BIS), in accordance with Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The BIS will serve as the certifying and enforcing authority for compliance with this order.

Title	Issue Date	View Order
Draft Order	21/02/2025	View

IMPOERTANT NOTES :

Any individual or entity found in violation of this order will be subject to penalties under the Bureau of Indian Standards Act, 2016.

Implementation Authority : Bureau of Indian Standards (Govt. of India)

Implementation Dates: --

For any queries on this update, write us at [email protected] or Call +91 9990136656

For more details visit: Aleph INDIA

Attachment: Standard Amendment Order issued by Bureau of Indian Standards

Disclaimer: The information provided in this update is intended for informational purposes only. Readers are requested to seek formal legal advice prior to acting upon any of the information provided herein.

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