1. Product Identification
Medical gloves, including surgeon’s and patient examination gloves, are used to prevent transmission of a wide variety of diseases to both patients and health care personnel. This manual contains information on the regulatory requirements for patient examination gloves and surgeon's gloves, as well as FDA’s recommendations for meeting those requirements.
Medical gloves are class I reserved devices and are subject to general controls (section 513(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c(a)(1)(A)), which include:
Establishment Registration and Device Listing
Premarket Notification 510(k)
Medical Device Reporting (MDR) – reporting of adverse events associated with a medical device.
You may obtain assistance on any regulatory issue from the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA). Contact information for DSMICA is the following:
Division of Small Manufacturers, International, and Consumer Assistance
Phone: 240-276-3150 or 800-638-2041
21 CFR 880.6250 Patient examination glove.
- Identification. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
- Classification. Class I (general controls).
Table 1.1 Patient Examination Glove, 21 CFR 880.6250
|Polymer – other than Vinyl
(includes Nitrile, Polyurethane, etc.)
|Specialty: Chemotherapy, etc.||
The subcategories of gloves described in Table 1.1 are all special forms of the category “patient examination glove.” These gloves should meet the requirements for a patient examination glove, as well as additional 510(k) and labeling recommendations described in the following paragraphs:
Specialty/Chemotherapy Labeling Claim. Medical gloves cleared for marketing with chemotherapy labeling claims (often referred to as chemotherapy gloves) are specialty patient examination gloves. These gloves should meet the current FDA-recognized consensus standard for patient examination gloves or an equivalent test method.
We recommend that you follow the 510(k) format for examination gloves outlined in Chapter 6 for chemotherapy glove 510(k) submissions. The 510(k) submission should also include permeation and penetration data based on actual testing with chemotherapeutic drugs.
For additional information, refer to Chemotherapy Labeling Claim in Chapter 4.
Dental Patient Examination Gloves . Gloves worn during dental cleaning, filling, and other dental procedures are patient examination gloves. These gloves should meet the requirements for patient examination gloves. You may use the term "dental" in the labeling of gloves intended for dentistry. The term “dental” should always be used with, and does not replace, the term “patient examination glove.”
21 CFR 878.4460 Surgeon’s glove.
- Identification. A surgeon’s glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This excludes the lubricating or dusting powder used in the glove.
- Classification. Class I (general controls).
Surgeon’s gloves are subject to the design control requirements of the Quality System regulation (21 CFR 820.30(a)(2)(ii)).
Surgeon’s gloves should be sterile when offered for sale to end users, such as hospitals, clinics, and surgeons. FDA has not cleared any 510(k)’s for non-sterile surgeon’s gloves. A 510(k) submission for surgeon’s gloves should include information about the sterilization method and cycle. The provisions in 21 CFR 801.150(e) regulate the shipment of medical gloves to and from a contract sterilizer. See Chapter 8 for additional information.
Table 1.2 Surgeon's Glove,21 CFR 878.4460
|Surgeon’s Glove (including Dental Surgeon’s gloves)
Orthopedic Surgeon’s Glove
Autopsy Surgeon’s Glove
Specialty/Chemotherapy Surgeon’s Glove
Radiation Attenuating Surgeon’s Gloves
The subcategories of gloves described in Table 1.2 are all special forms of the category “surgeon’s glove.” These gloves should meet the requirements for a surgeon’s glove as well as additional 510(k) and labeling recommendations described in the following paragraphs:
Dental Surgeon’s Glove . You may use the term "dental" in the labeling of gloves intended for dental surgery. Gloves for dental surgery may be thicker than standard surgeon’s gloves. The labeling may include the measured thickness of the gloves, but you should not use ambiguous terms such as "extra thick."
Microsurgery Glove . Microsurgery gloves are carefully processed to have decreased thickness in certain areas, particularly at the fingertips. To date FDA has not cleared any 510(k) submissions for microsurgery gloves that are thinner than the specifications in the FDA-recognized consensus standard for surgeon’s gloves. As with all surgeon’s gloves, testing should demonstrate safety and effectiveness for its indications for use.
Orthopedic Surgeon’s Glove . Orthopedic surgical gloves may be larger, thicker, and more resistant to tear than other surgical gloves. You may state the measured thickness and other parameters of orthopedic gloves in the labeling. You should not use ambiguous terms, such as "extra thick," or "super strong."
Autopsy Surgeon’s Glove . Autopsy gloves are intended for use during autopsy procedures and may be similar to orthopedic surgeon’s gloves. These gloves are subject to the same regulatory requirements as surgeon’s gloves.
Specialty/Chemotherapy Labeling Claim. We recommend that you follow the 510(k) format for surgeon’s gloves outlined in Chapter 7 for chemotherapy glove 510(k) submissions. The 510(k) should also include permeation and penetration data based on actual testing with chemotherapeutic drugs. We recommend that surgeon’s gloves with chemotherapy labeling claims follow the current FDA-recognized consensus standards for surgeon’s gloves or an equivalent test method.
For additional information, refer to Chemotherapy Label Claim (under Attribute Labeling) in Chapter 4.
Radiation Attenuating Surgeon’s Glove. Radiation attenuating surgeon’s gloves are used during surgical procedures involving radiation exposure to the hands. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes surgical procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for a surgeon’s glove, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.
A medical device kit may include medical gloves. Kit manufacturers and assemblers should assure that gloves in their kits are cleared for marketing and that the gloves can meet the appropriate FDA and ASTM standard (such as ASTM D3577, ASTM D3578, ASTM D5250, ASTM D6319) or an equivalent test method after the kit is sterilized.
We recommend that you enclose natural rubber latex gloves in their own packaging within the kit to avoid possible protein contamination of other devices. You must label the kit appropriately for any device or packaging containing natural rubber (21 CFR 801.437).
You may refer to the following documents for additional guidance:
Table 1.3 Classification codes for accessories
21 CFR 878.4460
|Surgeon’s Gloving Cream||
21 CFR 878.4470
Glove Liners/Undergloves . Glove liners or undergloves are worn with patient examination or surgeon’s gloves. They may be made of materials such as cotton to prevent the medical glove from contacting the user’s hand, or they may be made of materials that are resistant to cutting or puncture. The glove liners provide added protection by reducing the risk of a cut or puncture wound during surgical or examination procedures and by absorbing perspiration. Unless separately classified, accessories to medical gloves have the same classification (regulation number) as the gloves with which they are used.
Medical device regulations apply to glove liners and undergloves. Because glove liners and undergloves contact the skin, you should submit biocompatibility data with a 510(k) submission to show that they are safe for their intended use (See Chapter 3, Biocompatibility). If your labeling states that your glove liners provide a protective barrier, then the glove liners should meet the quality limit for barrier defects (pinholes) in the FDA-recognized consensus standard (or an equivalent standard) for the glove to which the liner is an accessory.
Surgeon’s Gloving Cream . Surgeon’s gloving cream lubricates the user’s hand before putting on a surgeon’s glove. This cream may also be used with examination gloves. FDA classified gloving cream as a class I device under 21 CFR 878.4470. Gloving cream is exempt from 510(k) submission requirements unless the intended use of the cream is different from that described in 21 CFR 878.4470, i.e., "lubricating the user's hand…." Gloving creams should not degrade the glove material in latex gloves or other gloves, i.e., the creams should not be oil-based. If a manufacturer modifies the ingredients of an existing gloving cream or introduces a new gloving cream into commercial distribution, the manufacturer should ensure that the cream performs as claimed. The manufacturer also should maintain biocompatibility data on file to show that the new or modified cream is safe and effective for the intended use.
Radiographic Protection Glove . FDA classified radiographic protection gloves as a "personnel protective shield" under 21 CFR 892.6500 (product code IWP). This is a class I device and is exempt from Premarket Notification (510(k)). The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. We recommend that you maintain technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.
If radiographic protection gloves are also intended for use as medical gloves, FDA classifies them as either patient examination gloves or surgeon’s gloves and they are subject to 510(k) clearance.
Leak Detectors . Leak detectors are chemical, electromechanical, or electronic systems designed for the glove user to monitor glove barrier integrity immediately before and during glove use. FDA classifies these devices as accessories to medical gloves. Leak detectors used as medical devices should have 510(k) clearance before marketing.
Leak testers and other equipment used during the production of gloves are production equipment; they are not medical devices. The Quality System regulation in 21 CFR 820.70 and 820.72 covers the selection, use, control, and maintenance of production equipment.
Embalming Gloves . The Occupational Safety and Health Administration (OSHA) regulates embalming gloves.
Food Service Gloves . FDA considers food service gloves to be a food contact surface which may result in the addition of indirect food additives to the food handled. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) regulates food service gloves.
Gloves used for food handling or preparation are not medical devices; therefore, they are not subject to the 510(k) premarket review process and thus are not cleared for marketing by FDA’s Center for Devices and Radiological Health (CDRH). Labeling of food service gloves should not, in any way, represent or suggest that they may be used for medical purposes. This may include the brand name and company name.
For further information regarding additives and food use of gloves, contact CFSAN at 301-436-2600 (phone) or firstname.lastname@example.org (email).
The National Sanitation Foundation (NSF) has developed a protocol for food service gloves identified as “P155: Disposable Food Contact Gloves”.
Cleaning Gloves. FDA does not regulate gloves that are used for routine janitorial functions in medical facilities. However, gloves that are used for cleaning patients, or cleaning or handling surfaces or items contaminated with patient waste or fluids are medical gloves and should meet the requirements for patient examination gloves.
Utility, industrial, or general purpose gloves are used for tasks that do not involve contact with patients or body fluids. Therefore, FDA does not regulate them as medical devices. It is illegal for manufacturers to relabel these gloves for medical use or to imply in their labeling that the gloves are suitable for medical use. Labeling of utility, industrial, and general purpose gloves should not, in any way, represent or suggest that they may be used for medical purposes. This may include the brand name and company name.