10. Voluntary Standards
Conformance with recognized consensus standards can help provide a reasonable assurance of safety and/or effectiveness for many aspects of medical devices. Conformance to consensus standards is voluntary and may be used to demonstrate performance or safety of a device.
Conformance with consensus standards will help establish the equivalence of a new glove to a legally marketed predicate glove in a Premarket Notification 510(k) submission. If a person elects to use a standard recognized by FDA to meet a premarket submission requirement (or other requirement under the Act to which such standard is applicable), the person must provide a declaration of conformity to the FDA that certifies the device is in conformity with the standard (section 514(c)(1)(B) of the Act (21 USC 360d(c)(1)(B)). At any time, FDA may request the data or information relied on by the person to make a declaration of conformity (section 514(c)(3)(B)). A person making a declaration of conformity must maintain the data and information demonstrating conformity for a period of two years after the date of the classification or approval of the device by FDA or a period equal to the expected design life of the device, whichever is longer (514(c)(3)(C)).
The manufacturer should submit the declaration of conformity in the Abbreviated 510(k) method. Consensus standards may also be used in the Traditional 510(k) method to help establish equivalence. See FDA guidances “The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” and “Use of Standards in Substantial Equivalence Determinations” for additional information on the use of consensus standards in 510(k) submissions.
Information on FDA’s standard program, including a database of FDA-recognized standards, can be found on the following website:
CDRH Standards Program
At this time FDA recognizes the following standards:
Patient Examination Gloves
|D5151||Standard Test Method for Detection of Holes in Medical Gloves|
|D6124||Standard Test Method for Residual Powder on Medical Gloves|
|D3577||Standard Specification for Rubber Surgical Gloves|
You can find current FDA-recognized standards in the CDRH standards database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Search.cfm
In addition to FDA-recognized standards, manufacturers may use other consensus standards. As discussed earlier, under the Act, only FDA-recognized standards are those for which you may submit a declaration of conformity in order to meet a premarket requirement; however, you may find other consensus standards that have not been recognized by FDA useful. Below is a list of some of the standards applicable to medical gloves.
|ANSI/ADA76||Non-sterile latex gloves for dentistry.|
|ADA Spec No. 102||Non-sterile nitrile gloves for dentistry.|
|ASTM D5250||Standard specification for poly(vinyl chloride) gloves for medical application.|
|ASTM draft||Standard specification for nitrile examination gloves for medical application.|
|ISO10282||Single-use surgical rubber gloves-Specification.|
|ISO11193||Single-use rubber examination gloves-Specification.|
|AS/NZS 4011||Single-use examination gloves—specification.|
|EN 455-1||Medical gloves for single use. Part 1. Specification for freedom from holes.|
|EN 455-2||Medical gloves for single use. Part 2. Specification for physical properties.|
|CAN 20.27-M91||Sterile or non-sterile medical examination gloves for single use.|
|MS1155||Malaysian standard for rubber examination glove.|
|JIS T 9107||Japanese Industrial Standard. Surgical gloves.|
|ASTM D412||Test methods for vulcanized rubber and thermoplastic rubbers and thermoplastic elastomers—tension.|
|ASTM D573||Test method for rubber—deterioration in an air oven.|
|ASTM D3767||Practice for Rubber—measurement of dimensions.|
|ISO 2859||Sampling procedures and tables for inspection by attributes.|
|ISO 37-94||Method for determination of tensile stress-strain properties (to determine the force at break)|
|ISO 188||Heat resistance and accelerated aging tests.|
|ISO 4648||Physical testing of rubber. Methods for the determination of dimensions of test pieces and products for test purpose.|
|ASTM D7160||Standard Practice for Determination of Expiration Dating for Medical Gloves|
|ASTM D7161||Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions|
|ADA||American Dental Association|
|ANSI||American National Standards Institute|
|CAN||National Standard of Canada|
Each manufacturer that distributes patient examination or surgeon's gloves in the U.S. should have in its files at the manufacturing site an original copy of each pertinent standard referenced by the manufacturer's Quality System device master record(s) and/or 510(k) submission(s). During an inspection, the FDA investigator may ask to see a copy of each referenced standard and any data demonstrating that the gloves conform to the standard.
You may purchase standards from the following organizations.