Compliance Policy Guide  
Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; 
Defects - Criteria for Direct Reference Seizure 
 
Guidance for FDA Staff  
 
This document supersedes Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; 
Defects - Criteria for Direct Reference Seizure, dated July 2005 
 
Issued by: 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
March 2011 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.   
 
I.  Introduction:  
 
This CPG provides guidance to FDA staff on the submission of seizure recommendations for 
medical gloves that exceed the defect levels in 21 CFR 800.20.   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
II. Background:  
 
Surgeons and patient examination gloves have been increasingly relied upon by health care 
workers as a barrier to the transmission of Human Immunodeficiency Virus (HIV) and other 
blood and fluid-borne infectious agents. * * In view of the rapid increase in demand for 
imported and domestically produced gloves, and the public health benefits of further reducing 
the risk of transmission of HIV and other blood and fluid borne infectious agents, and to better 
utilize Agency resources, on November 21, 1989, FDA published in the Federal Register 
proposed rules to insure that *gloves manufactured for medical use and distribution in the 
United States* are not adulterated.  The final rule, *entitled "Patient examination gloves and 
surgeons gloves; sample plans and test method for leakage defects; adulteration",* was 
published on December 12, 1990, at 55 FR 51254.  It was amended on December 19, 2006 at 
     
 
71 FR 75876, with an effective date of December 19, 2008.  It is codified at 21 CFR 800.20.*  
 
*FDA will collect samples from lots of gloves using the sample sizes and inspection levels in 21 
CFR 800.20(c), and test for defects using the test methods in 21 CFR 800.20(b).*  The 
sampling inspection plan used by the FDA is derived from *ISO-2859 (the International 
Organization for Standardizations* standard for "Sampling Procedures and Tables for 
Inspection by Attributes"), based on general inspection level II, normal inspection, and an 
acceptable quality level (AQL) of *1.5%* for surgeons gloves and *2.5%* for patient 
examination gloves.  Single sampling will be used for lots less than or equal to 1200 gloves, 
while multiple sampling will be used for larger lots. 
 
III. Policy:  
 
Surgeons gloves and patient examination gloves that contain holes are adulterated devices.  
Adulteration will be determined on a lot by lot basis for enforcement purposes.  *FDA considers 
a lot of medical gloves to be adulterated within the meaning of section 501(c) of the Federal 
Food, Drug, and Cosmetic Act, 21 U.S.C. 351(c), when the number of defective gloves found in 
the tested sample meets or exceeds the applicable rejection number at the 1.5 AQL for 
surgeons gloves or the 2.5 AQL for patient examination gloves.  See 21 CFR 800.20(c)(3).*    
 
IV.   Regulatory Action Guidance:  
 
Lots of surgeons and patient examination gloves that *are sampled, tested, and rejected using 
the procedures in 21 CFR 800.20* are subject to administrative and judicial action, such as 
detention of imported products and direct reference seizure of domestic products.  * *  
SPECIMEN CHARGES:  
"The article of device is adulterated within the meaning of the Act, 21 U.S.C. 351(c), in that its 
quality falls below that which it purports or is represented to possess because its defect rate 
exceeds the permissible rate for medical gloves set forth at 21 CFR 800.20."  
Sample language for the letter to the U.S. Attorney:  
Medical gloves are intended for use by health professionals, such as physicians and dentists, 
during surgery and routine medical and dental examinations, and by health care technicians 
and associated workers.  All rely on medical gloves as an effective barrier against the 
transmission and spread of disease and blood and fluid-borne infectious agents.  An effective 
barrier is increasingly essential in light of the current Human Immunodeficiency Virus and 
Acquired Immune Deficiency Syndrome epidemic, and the potential for a pandemic influenza.  
We request seizure because analyses of the gloves by the Food and Drug Administration (FDA) 
shows that their quality falls below that which they purport or are represented to possess 
because the defect rate of the gloves exceeds the permissible level set forth in 21 CFR 800.20. 
___ out of ___ gloves tested were found to leak or contain holes. 21 U.S.C. 351(c).  
 
*Material between asterisks is new or revised.* 
 
Issued: 05/31/1991 
Revised:  03/2011 
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