GEM

GMCH Chandigarh Disposable Surgical Rubber Gloves Tender 2025 IS 13422 MDR 2017 Compliance and 100000 EMD

Posted

27 Oct 2025, 04:32 pm

Deadline

06 Nov 2025, 05:00 pm

EMD

₹1,00,000

Progress

Issue27 Oct 2025, 04:32 pm
AwardPending
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Quantity

500000

Bid Type

Two Packet Bid

Categories 2

Tender Overview

Government Medical College And Hospital (Chandigarh) seeks supply of disposable surgical rubber gloves under a procurement that enforces IS 13422 compliance for glove type, material, powder status, size per latest IS 13422, and dimensional tolerance. The contract requires MDR 2017 compliance, a valid medical device license under the Drugs and Cosmetics Act, and batch-wise test reports. An advance sample may be provided for buyer approval post-award. The EMD is ₹100,000; scope is pure supply, with potential quantity adjustments per option clause up to 25%. This tender emphasizes packaging, marking, and shelf life alignment with the latest IS 13422 revisions, ensuring delivery with minimum shelf life at delivery. The procurement targets GMP-ready gloves for medical use, including packaging and labeling as per standards, with performance and traceability demonstrated through required certification packets.

Technical Specifications & Requirements

  • Glove Type: as per IS 13422 (Latest)
  • Material: unspecified (to be supplied per IS 13422 requirements)
  • Powder: specified in product information; ensure powder-free or as per IS 13422
  • Size: per IS 13422 (Latest); confirm range and control of dimensions
  • Dimensions & Thickness: tolerance per IS 13422 (Latest)
  • Packaging & Marking: per IS 13422 (Latest Revision)
  • Certifications: MDR 2017 compliance; valid medical device license under Drugs and Cosmetics Act; manufacturing unit certification; batch-wise test reports
  • Tests & Reports: provide test reports for each batch; submit licenses and certifications with bid
  • Shelf Life: minimum shelf life at delivery; specify months from manufacture; ensure minimum viability on receipt
  • Advance Sample: bidder to provide advance sample for approval after contract award

Terms, Conditions & Eligibility

  • EMD: ₹100,000
  • Delivery Scope: supply-only; no works
  • Option Clause: purchaser may increase/decrease quantity by up to 25% at contracted rates; extended delivery time computed from original/extended periods with minimum 30 days
  • Integrity Pact: must submit during bidding
  • Non-Blacklisting: affidavit required between bid publish and opening dates
  • Price Fall Clause: must be submitted with bid
  • Documents: GST, PAN, experience certificates, financial statements, EMD submission, OEM authorization, MDR licenses, test reports, manufacturing certifications
  • Delivery & Payment Terms: explicit terms to be complied with per buyer’s ATC; verify payment conditions in final bid
  • Shelf Life & Samples: ensure minimum shelf life at delivery; submit advance sample for approval post-award

Key Specifications

    • Product: Disposable surgical rubber gloves as per IS 13422 (Latest)
    • Glove Type/Size: IS 13422 compliant; sizes as per standard and dimensions
    • Material & Powder: material specification per IS 13422; powder status specified in product info
    • Packaging & Marking: conform to IS 13422 (Latest Revision); labeling requirements
    • Standards: IS 13422 (Latest); MDR 2017 compliance; valid medical device license under Drugs and Cosmetics Act
    • Quality & Testing: batch-wise test reports; test certificates for each batch
    • Shelf Life: minimum shelf life at delivery; months from manufacture
    • Adv Samples: advance sample provision post-award

Terms & Conditions

  • EMD of ₹100,000 required with bid submission

  • Option clause allows ±25% quantity variation at contracted rates

  • MDR 2017 compliance and Drugs and Cosmetics Act license mandatory

  • Batch test reports and manufacturing certifications must be submitted

  • Advance sample to be provided for buyer approval after award

Important Clauses

Payment Terms

Payment terms to be as per ATC; confirm whether advance, milestone, or after delivery applies

Delivery Schedule

Delivery period may extend with option clause; minimum 30 days for additional time

Penalties/Liquidated Damages

LD/penalties details to be specified in buyer ATC; submit terms with bid

Bidder Eligibility

  • Experience in supplying disposable surgical gloves or similar medical devices

  • Valid MDR compliance and medical device license under Drugs and Cosmetic Act

  • Manufacturing unit certification and batch test capability

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Disposable Surgical Rubber Gloves
GENERAL Sterility Sterile
GENERAL Usage Single Use
STANDARD Conformity to standard IS:13422 (Latest)
PRODUCT INFORMATION Glove Type (as per IS 13422 ) Type 1
PRODUCT INFORMATION Material Natural Rubber Latex Concentrate
PRODUCT INFORMATION Powder Powdered
PRODUCT INFORMATION Size of gloves as per IS 13422 (Latest) 7.5
PRODUCT INFORMATION Dimensions, Tolerance on dimensions and Thickness of the gloves shall be as per IS 13422 (Latest) Yes
PACKAGING & MARKING Packaging & Marking shall be as per IS 13422 (Latest Revision) Yes
PACKAGING & MARKING Packing Type Gloves packed in pairs in unit packs
CERTIFICATIONS & REPORTS Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Availability of valid medical device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
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 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 registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates for similar glove supply

4

Financial statements (latest audited/management accounts)

5

EMD payment proof

6

Technical bid documents and compliance certificates

7

OEM authorization/Manufacturer’s certificate

8

MDR compliance certificates and Drugs and Cosmetics Act medical device license

9

Manufacturing unit certification

10

Batch test reports for gloves

11

Integrity pact

12

Non-blacklisting affidavit

13

Price Fall Clause affidavit

Frequently Asked Questions

How to participate in glove tender in Chandigarh 2025 with IS 13422 compliance

Bidders must submit GST, PAN, MDR licenses, manufacturing certifications, batch test reports, and integrity pact. Ensure glove type and size meet IS 13422 latest edition, provide advance sample after award, and include ₹100,000 EMD. Delivery terms follow option clause up to 25%, with MDR-compliant packaging and labeling.

What documents are required for disposable glove procurement in GMCH Chandigarh

Required documents include GST certificate, PAN card, experience certificates for similar supply, audited financial statements, EMD proof, MDR licenses, medical device manufacturing certifications, OEM authorizations, batch test reports, integrity pact, and non-blacklisting affidavit. Ensure submission with bid and supply readiness.

What are the technical specifications for IS 13422 gloves in this tender in Chandigarh

Glove type, material, powder status, and size must align with IS 13422 (Latest). Dimensions and thickness must meet IS 13422 tolerances. Packaging and marking should follow IS 13422 latest revision and batch test reports must accompany each delivery batch.

What is the EMD amount and how is it paid for this bid in Chandigarh

EMD is ₹100,000. Submit via specified payment method with bid submission. Ensure EMD is valid and accompanied by bid documents; float and eligibility checks will require EMD submission before bid opening.

What is the delivery period and option clause impact for glove supply in GMCH

Delivery can vary; purchaser may adjust quantity by up to 25%. Additional time is calculated as (increased quantity ÷ original quantity) × original delivery period, with a minimum of 30 days. Original delivery period remains baseline for extension calculations.

What certifications and licenses are mandatory for this disposable glove tender

Mandatory MDR compliance, valid medical device license under Drugs and Cosmetics Act, manufacturing unit certification, and batch test reports for each supplied batch. Submit these licenses and test documents to the buyer at bid submission and with supplies.

What is required for advance sample submission in this GMCH Chandigarh tender

An advance sample must be provided after contract award and before commencement of supply. The sample helps buyer approve product type, packaging, labeling, and conformity to IS 13422 (Latest). Ensure sample matches requested glove specifications.

What packaging and labeling standards apply to IS 13422 gloves

Packaging and marking must follow IS 13422 (Latest Revision). Include batch number, expiry, manufacturer, size, and compliance marks. Ensure tamper-evident packaging and clear labeling aligned with regulatory requirements.