GEM

Eastern Railway Surgical Rubber Gloves Tender 2025 IS 4148 MDR 2017 BIS Certification

Posted

28 Oct 2025, 09:26 am

Deadline

11 Nov 2025, 10:00 am

Progress

Issue28 Oct 2025, 09:26 am
AwardPending
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Quantity

100400

Bid Type

Single Packet Bid

Tender Overview

The Eastern Railway (Indian Railways) invites bids for supply, installation, testing and commissioning of surgical rubber gloves (V2) – Q2 category. Although exact quantity and value are not disclosed, the scope encompasses batch-wise provision with IS 4148 (Latest) dimensional tolerances and packaging standards, plus mandatory certifications. A 25% quantity upsize/downsize option is stated, with extended delivery timelines in line with the contract. Proposals must include BIS certification and adherence to Medical Device Rules (MDR) 2017. An advance sample must be provided post-award for buyer approval.

Technical Specifications & Requirements

  • Product: Surgical rubber gloves (V2) – Q2
  • Standards & Compliance: Dimensions and thickness as per IS 4148 (Latest); Packing & marking per IS 4148 (Latest)
  • Material/Color/Finish: Material, color, and outer surface finishing as specified in the bid
  • Size & Measurements: Glove size, dimensions, tolerance per IS 4148 (Latest)
  • Certifications/Reports: BIS certificate (IS 13422 or IS 4148); MDR 2017 batch test reports; submission of all certifications at bid and/or supply
  • Shelf Life: Shelf life in months from manufacture, minimum shelf life at delivery
  • Advance Sample: Mandatory advance sample post-award for approval
  • Scope of Supply: Supply, installation, testing and commissioning included
  • Manufacturing Certification: Required as part of vendor eligibility

Terms, Conditions & Eligibility

  • Option Clause: Purchaser may ±25% quantity at contract rates; extended delivery time calculated as (additional quantity/original quantity) × original delivery period, with a minimum 30 days
  • Bidder/OEM Certificates: Must possess BIS certificate (IS 13422 or IS 4148); non-compliance may lead to rejection
  • Documentation & Submission: Upload BIS-related certificates and MDR/test reports with bid; provide required licenses and certifications at submission or with supply
  • Supply Scope: Includes delivery, installation, testing and commissioning; compliance with product and packaging standards is mandatory
  • Quality & Compliance: Adherence to MDR 2017 amendments and IS 4148 specifications is essential for eligibility

Key Specifications

  • Product: Surgical rubber gloves (V2) – Q2

  • Dimensions and thickness: IS 4148 (Latest) compliant

  • Packing & marking: IS 4148 (Latest) compliant

  • Materials: specified in product information

  • Color: specified in product information

  • Outer surface finishing: specified in product information

  • Size: glove size per IS 4148 with tolerances

  • Certification: BIS (IS 13422 or IS 4148); MDR 2017 test reports

  • Shelf life: months from manufacture; minimum shelf life at delivery

  • Advance sample: to be provided post-award

Terms & Conditions

  • Quantities may vary by ±25% with extended delivery time as per contract

  • BIS IS 13422 or IS 4148 certification mandatory for bid eligibility

  • MDR 2017 batch test reports required at bid submission or delivery

Important Clauses

Payment Terms

Not specified in provided data; bidders should expect standard government procurement terms per Eastern Railway

Delivery Schedule

Delivery period linked to original delivery order; additional time computed for option quantity per formula with a 30-day minimum

Penalties/Liquidated Damages

Not specified in data; be prepared for LDs as per standard contract terms

Bidder Eligibility

  • Must possess BIS certificate (IS 13422 or IS 4148) prior to bid opening

  • Must provide MDR 2017 test reports for each batch

  • Must meet supplier qualifications for surgical glove supply and comply with IS 4148 standards

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Surgical Rubber Gloves
STANDARD Conformity to standard IS 4148 (Latest)
PRODUCT INFORMATION Material Natural Rubber Latex
PRODUCT INFORMATION Color Transparent, Translucent
PRODUCT INFORMATION Outer Surface Finishing Rough, Smooth
PRODUCT INFORMATION Size of gloves 6.5
PRODUCT INFORMATION Dimensions, Tolerance on dimensions and Thickness of the gloves shall be as per IS 4148 (Latest) Yes
PACKAGING & MARKING Packing & marking shall be as per IS 4148 (Latest) Yes
PACKAGING & MARKING Packing Type Gloves packed in pairs in unit packs
CERTIFICATIONS & REPORTS Manufacturing unit certification ISO:13485 (Latest)
CERTIFICATIONS & REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement Yes
Shelf Life Shelf life in months from the date of manufacture 36, 48, 60 Or higher
Shelf Life Minimum shelf life available at the time of delivery to the consignee 3/4 th of Total Shelf Life
ADVANCE SAMPLE Agree to provide advance sample of the product for buyer's approval after award of contract and before commencement of supply in case of bidding only Yes

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Required Documents

1

GST certificate

2

PAN card

3

Experience certificates (similar glove supply projects)

4

Financial statements (or viability documents)

5

EMD/Security deposit documentation (if applicable)

6

Technical bid documents showing compliance with IS 4148 and MDR 2017

7

OEM authorization letters (if bidding as dealer/distributor)

8

BIS certificates (IS 13422 or IS 4148)

9

Test reports for each batch as per Medical Device Rules (MDR) 2017

10

Manufacturing unit certification

Frequently Asked Questions

How to bid for surgical gloves tender in Eastern Railway

Bidders must be BIS certified (IS 13422 or IS 4148) and provide MDR 2017 batch test reports. Submit GST, PAN, experience proofs, financial statements, and OEM authorizations. Include advance sample post-award and comply with IS 4148 for dimensions and packing.

What documents are required for IS 4148 gloves tender submission

Submit BIS certificate (IS 13422 or IS 4148), MDR batch test reports, manufacturing unit certification, GST, PAN, experience certificates, and financial statements. Upload technical bid documents demonstrating IS 4148 conformity and packing standards at bid submission.

What are the key technical specifications for surgical gloves

Gloves must meet IS 4148 (Latest) for dimensions, thickness, size tolerance, outer surface finishing, and packing/marking. Material and color details are defined in product information; advance samples required after contract award for buyer approval.

What is the upsize/extension option for quantity in this tender

The purchaser may increase or decrease quantity by up to 25% of bid quantity at contract award and during contract currency, with delivery time recalculated accordingly and a minimum of 30 days extra time.

When are MDR batch test reports required for bid submission

MDR 2017 batch test reports must be available for each supplied batch and submitted with the bid or along with supplies, ensuring compliance with Medical Device Rules as amended.

What are the certification requirements for bidder eligibility

Bidder must attach BIS certificate (IS 13422 or IS 4148) and provide test reports per MDR 2017; failure to provide these may result in bid rejection.

What is included in the scope of supply for gloves tender

Scope includes supply, installation, testing and commissioning of surgical gloves, with packaging per IS 4148 and advance sampling for buyer approval post-award.

What are the minimum shelf life requirements for delivered gloves

Tenders require a minimum shelf life from manufacture as specified; ensure supplier can guarantee shelf life at delivery in months and provide relevant certification.

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