CDSCO risk classification
Personal Protective Equipment medical device classification
Every personal protective equipment device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 14 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 33
- Class A
- 26
- Class B
- 7
- Class C
- 0
- Class D
- 0
Personal Protective Equipment devices and their class
33 devices
Biosanitizer for Medical devices
Personal Protective Equipment
Class BIntended for surface disinfection of medical devices, non porous hard-surfaces, medical-equipment, units, as well as in-depth cleaning of small surfaces.
chemotherapy spill clean-up kit
Personal Protective Equipment
Class ADesigned to safely clean and dispose of Chemotherapy drug spills.
Face shield
Personal Protective Equipment
Class ANon-sterile, non-measuringIntended to protect the wearer's entire face (or part of it) from hazards such as chemical splashes (in laboratories or in industry), or potentially infectious materials (in medical and laboratory environments).
Garment, Protective for Incontinence
Personal Protective Equipment
Class AIntended to protect an incontinent patients garment from the patients excreta.
Gonadal radiation protector
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that attenuates unnecessary radiation exposure in diagnostic, medical or dental procedures, and shields the gonad of the patient and the operator.
Isolation Gown (Non-Sterile)
Personal Protective Equipment
Class AA non-sterile garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect the themselves from a contagious agent which has infected the patient.
Isolation Gown) (Sterile)
Personal Protective Equipment
Class BA sterile garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect the themselves from a contagious agent which has infected the patient.
Latex medical examination glove
Personal Protective Equipment
Class ANatural rubber gloves used to protect the patient and users from cross infection during examination, check-up, treatment and handling of contaminated medical materials except for surgery.
Latex surgical glove
Personal Protective Equipment
Class BNatural rubber based glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery.
Medical/Cadaver Body Bags
Personal Protective Equipment
Class AIntended for transporting a human corpse without any spread of biohazard/infectious agent.
Mobile radiation protection barrier
Personal Protective Equipment
Class ANon-sterile, non-measuringA stand-alone, movable barrier that protects the operator etc. from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures.
Non-latex medical examination glove
Personal Protective Equipment
Class AGloves made of synthetic materials, and used to protect the patient and users from cross infection during examination, check-up, treatment and handling of contaminated medical materials except for surgery.
Non-latex surgical glove
Personal Protective Equipment
Class BSynthetic material glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery.
Operating Room Shoes Cover
Personal Protective Equipment
Class AIntended to be worn by operating room personnel during surgical procedures to protect foot of both the surgical patient & the operating room personnel from transfer of micro-organisms, body fluids, and particulate material.
Operator radiation protection spectacles
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment.The device comes in non-correction (non-prescription) glasses and visual acuity correction (prescription) glasses.
Partial hand radiation protector
Personal Protective Equipment
Class ANon-sterile, non-measuringA flat pad with straps or partial gloves that protect part of hands and fingers from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures.
Patient Gown
Personal Protective Equipment
Class AA garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment.
Personal Protective Equipment
Personal Protective Equipment
Class BPPE kit used to acts as a barrier between infectious materials such as viral and bacterial contaminants and skin, mouth, nose, or eyes. It refers to protective clothing, helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
Professional Examination Gown
Personal Protective Equipment
Class AA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids.
Radiation face protector
Personal Protective Equipment
Class ANon-sterile, non-measuringA transparent or opaque personal protection device that protects the face and eyes of medical personnel and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment.
Radiation protection apron
Personal Protective Equipment
Class ANon-sterile, non-measuringA standard length or half-length apron to protect the patient, the operator, and other personnel from radiation exposure during a medical or dental procedure. Some have a fixed or removable collar to protect the neck and thyroid.
Radiation protection blanket
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that protects specific body parts of the patient, operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment.
Radiation protection cap
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that protects the head of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical procedures for diagnosis and treatment.
Radiation protection collar
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that protects the neck or thyroid of the patient, the operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment.
Radiation protection gloves
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that completely protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures.
Radiation protection goggles
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical/dental procedures for diagnosis and treatment.
Radiation protection mitten
Personal Protective Equipment
Class ANon-sterile, non-measuringA personal protection device that protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. The mittens are also called mitts, and protect the thumb and other fingers individually or together.
Surgical Cap
Personal Protective Equipment
Class AIntended to protect face of patient & the operating room personnel from the transfer of micro-organisms, body fluids & particulate material.
Surgical Drape & Drape Accessories
Personal Protective Equipment
Class BA surgical drape & drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial & other contamination.
Surgical gown (Non-Sterile)
Personal Protective Equipment
Class AA non-sterile garment made of natural and/or synthetic materials intended for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Surgical gown (Sterile)
Personal Protective Equipment
Class BA sterile garment made of natural and/or synthetic materials intended for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Surgical gown, non-sterile/ Operating room gown
Personal Protective Equipment
Class ANon-sterile, non-measuringA non-sterile garment intended to be worn by health care staff over a scrub suit for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a reusable garment.
Surgical Helmet
Personal Protective Equipment
Class AIntended to protect healthcare workers from contaminants & debris on head.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
Other categories
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