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U.S. Department of Health and Human Services

Medical Devices

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10. Voluntary Standards

INTRODUCTION

FDA-RECOGNIZED CONSENSUS STANDARDS

OTHER CONSENSUS STANDARDS

INTRODUCTION

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.

FDA-RECOGNIZED CONSENSUS STANDARDS

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
http://www.fda.gov/cdrh/stdsprog.html

At this time FDA recognizes the following standards:
 

Patient Examination Gloves

ASTM 

D5151 Standard Test Method for Detection of Holes in Medical Gloves

ASTM 

D6319 Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM 

D6124 Standard Test Method for Residual Powder on Medical Gloves

ASTM 

D5250 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

ASTM 

D3578 Standard Specification for Rubber Examination Gloves

ASTM 

D3772 Standard Specification for Rubber Finger Cots

 

Surgeon’s Gloves

ASTM 

D5151 Standard Test Method for Detection of Holes in Medical Gloves

ASTM 

D6124 Standard Test Method for Residual Powder on Medical Gloves

ASTM 

D3577 Standard Specification for Rubber Surgical Gloves

Test Methods

ASTM 

D5712 Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

ASTM 

D6499 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products

ASTM 

D5151 Standard Test Method for Detection of Holes in Medical Gloves

ASTM 

D6124 Standard Test Method for Residual Powder on Medical 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

OTHER CONSENSUS STANDARDS

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.

Glove Standards
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.
Test Standards
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.

Expiration Dating
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

 

Standard Organizations
ADA American Dental Association
ANSI American National Standards Institute
ASTM ASTM International
CAN National Standard of Canada
EN European Standard
ISO International Standard

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.

ANSI
11 West 42 nd Street
New York, New York 10036
Phone: 212-642-4900
Fax: 212-398-0023
http://www.ansi.org/

 

ASTM International
100 Barr Harbor Drive ,
West Conshohocken , PA19428-2959
Phone: (610) 832-9585
Fax: (610) 832-9555
http://www.astm.org