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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 6-180
Standard
ASTM F2407-06 (Reapproved 2013)
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
Scope/Abstract
1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. Four levels of barrier properties for surgical gowns are specified in AAMI PB70 and are included in this specification for reference purposes.

Note 1-Some properties require minimum performance and others are for documentation only.

Note 2-AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.

1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.

1.3 This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in purchase specifications as the basis for selecting test requirements.

1.4 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§878.4040 Gown, Isolation, Surgical Class 2 FYC
§878.4040 Gown, Surgical Class 2 FYA
Relevant FDA Guidance and/or Supportive Publications
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, Issued August 1993
FDA Technical Contact
 Elizabeth Claverie
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6298
  elizabeth.claverie@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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