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BIS ISI Certification for Disposable Surgical Rubber Gloves
Disposable surgical rubber gloves are essential medical devices used to prevent cross-contamination and protect both healthcare professionals and patients during surgical and medical procedures. In India, BIS ISI certification is mandatory for surgical gloves to ensure safety, sterility, and consistent performance.
BIS certification for Disposable surgical rubber gloves are covered under Indian Standard IS 13422 that specify requirements related to material quality, tensile strength, freedom from holes, sterility, dimensions, and labeling. These standards ensure that gloves are safe for direct contact with patients and bodily fluids.
BIS ISI Mark certification enables manufacturers to legally manufacture and sell disposable surgical gloves in India and builds trust among hospitals, healthcare institutions, and regulatory authorities.
Key Quality & Performance Requirements for Disposable Surgical Rubber Gloves
- (i) Manufacture from high-quality natural rubber latex or approved material
- (ii) Adequate tensile strength and elongation properties
- (iii) Freedom from pinholes and surface defects
- (iv) Proper dimensions, thickness, and glove length
- (v) Sterility assurance for surgical use
- (vi) Biocompatibility and non-toxicity to skin
- (vii) Resistance to tearing during surgical procedures
- (viii) Mandatory marking, batch identification, and ISI Mark
Overview of ISI Mark Certification for Disposable Surgical Rubber Gloves
BIS certification ensures that disposable surgical rubber gloves meet stringent Indian quality and safety standards required for medical and surgical applications. These gloves are designed to act as a protective barrier against microorganisms, blood, and body fluids.
The applicable Indian Standards specify requirements for material composition, physical properties, sterility, freedom from holes, and packaging to ensure consistent quality and safety for clinical use.
BIS grants ISI Mark certification for disposable surgical gloves only after successful factory inspection, evaluation of quality control systems, and testing of samples in BIS-recognized laboratories. Certified gloves are authorized to carry the ISI Mark, confirming compliance with Indian Standards.
Process Required for BIS ISI Mark Certification for Disposable Surgical Rubber Gloves
To obtain the BIS ISI Mark for Disposable Surgical Rubber Gloves, manufacturers must comply with the BIS Product Certification Scheme (Scheme-I). This certification ensures that surgical gloves meet mandatory requirements related to material quality, sterility, physical strength, and safety before being manufactured or sold in India.
Estimated Timeline: BIS ISI certification for surgical gloves generally takes around 30–45 days for Indian manufacturers, subject to factory readiness, inspection scheduling, and laboratory testing.
Step-by-Step Certification Process
- Application Submission: Submit the BIS application through the Manak Online portal with product details, applicable Indian Standard for surgical gloves, factory address, manufacturing process, and quality control setup.
- Testing Readiness: Ensure availability of testing facilities for freedom from holes, tensile strength, elongation, dimensions, sterility, and biocompatibility as prescribed under the applicable BIS standard.
- Factory Inspection: BIS officials conduct an on-site inspection to verify raw material control, dipping and curing process, sterilization methods, in-house testing facilities, and compliance with the Scheme of Inspection and Testing (SIT).
- Sample Drawing and Testing: Surgical glove samples are drawn during inspection and tested in BIS-recognized laboratories.
- Grant of BIS License: Upon satisfactory inspection and successful test results, BIS grants the Certification Marks License (CM/L), authorizing the manufacturer to use the ISI Mark on surgical gloves.
Requirements to Obtain BIS License for Disposable Surgical Rubber Gloves
- Compliance of surgical gloves with material, physical, and safety requirements specified under applicable Indian Standards.
- Use of high-quality natural rubber latex or approved synthetic material suitable for surgical use.
- Availability of testing facilities for freedom from holes, tensile strength, elongation, dimensions, sterility, and visual inspection.
- Appointment of qualified quality control personnel to ensure consistent production conformity and sterility assurance.
- Strict adherence to the Scheme of Inspection and Testing (SIT) and BIS ISI certification guidelines applicable to medical gloves.
To obtain BIS ISI certification for Disposable Surgical Rubber Gloves under Product Certification Scheme-I, manufacturers must submit the following documents:
- Administrative Details: Business registration documents, factory address proof, GST registration, and statutory approvals.
- Technical Details: Glove specifications, material composition, size range, thickness, manufacturing process, and compliance declaration.
- Quality Control Details: In-house testing capability, sterilization validation records, calibration certificates, and QC personnel details.
- Commercial Details: Brand name, trademark ownership (if applicable), and authorization documents.
Cost of BIS ISI Certification for Disposable Surgical Rubber Gloves
The following are indicative statutory charges involved in obtaining BIS ISI certification for surgical gloves under Product Certification Scheme-I. All government fees are payable directly to the Bureau of Indian Standards (BIS).
| S. No. | Particular | Amount (INR) | Remarks |
|---|---|---|---|
| 1 | Application Fee | ₹1,000 | Payable to BIS |
| 2 | Inspection / Audit Fee | ₹7,000 | Payable to BIS |
| 3 | Product Testing Fee | As applicable | Depends on glove type & laboratory |
| 4 | Marking Fee | As per BIS norms | Based on annual production |
Important Note: Product testing and sterility validation are critical stages of the BIS ISI certification process. BIS may conduct a factory pre-assessment to evaluate readiness prior to inspection. Costs may vary depending on glove type and testing scope.
Benefits of Getting ISI Mark Certification for Disposable Surgical Rubber Gloves
Obtaining the ISI Mark for Disposable Surgical Rubber Gloves provides critical regulatory, safety, and commercial advantages. ISI certification confirms that surgical gloves comply with Indian Standards for material quality, sterility, physical strength, and barrier protection, making them legally approved for medical and healthcare use in India.
1. Mandatory Legal Compliance
Disposable surgical gloves are regulated medical devices in India. ISI Mark certification is mandatory for lawful manufacturing, sale, import, or supply of surgical gloves in the Indian market.
2. Acceptance in Hospitals & Healthcare Institutions
ISI-certified surgical gloves are widely accepted in hospitals, operation theatres, clinics, laboratories, and healthcare facilities. Certification simplifies procurement approvals and compliance audits.
3. Assured Safety, Sterility & Performance
Certified gloves are tested for freedom from holes, tensile strength, elongation, dimensions, sterility, and biocompatibility, ensuring safe and reliable protection for medical professionals.
4. Enhanced Brand Credibility & Market Trust
The ISI Mark builds strong confidence among hospitals, doctors, procurement authorities, and regulators. Certified gloves are recognized as compliant with national quality and safety standards.
5. Competitive Advantage & Business Growth
ISI-certified surgical gloves gain preference in government tenders, hospital supply contracts, and institutional procurement, enabling manufacturers to expand market reach and credibility.
Frequently Asked Questions (FAQs) – BIS ISI Certification for Disposable Surgical Rubber Gloves
1. Is BIS ISI certification mandatory for disposable surgical gloves?
Yes. Disposable surgical rubber gloves are regulated medical devices in India. BIS ISI Mark certification is mandatory before manufacturing, importing, selling, or supplying surgical gloves in the Indian market.
2. Which Indian Standard applies to surgical gloves?
Surgical gloves are governed by applicable Indian Standards notified by BIS for disposable surgical rubber gloves, covering material, performance, sterility, and safety requirements.
3. What are the key quality requirements for surgical gloves?
Key requirements include freedom from holes (AQL), tensile strength, elongation, dimensions, sterility, biocompatibility, and absence of harmful substances.
4. What tests are conducted during BIS certification for surgical gloves?
Testing includes visual inspection, freedom from holes, tensile strength, elongation, dimensions, sterility testing, and chemical safety evaluation in BIS-recognized laboratories.
5. What happens if non-ISI certified surgical gloves are supplied?
Supplying non-ISI certified surgical gloves may result in penalties, product seizure, rejection in hospital procurement, and legal action under the Bureau of Indian Standards Act, 2016.
