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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 6-402
Standard
ASTM  F1670/F1670M-17
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
Scope/Abstract
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration.
1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood.
1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671.
1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.
1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction and components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
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.
Transition Period
FDA recognition of ASTM F1670/F1670M-17 [Rec# 6-402] will be superseded by recognition of ASTM F1670/F1670M-17a [Rec# 6-491]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-402] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-402] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4040 Gown, Surgical Class 2 FYA
§878.4040 Gown, Isolation, Surgical Class 2 FYC
§878.4370 Drape, Surgical Class 2 KKX
Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes. Issued August 1993.

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Guidance for Industry and Food and Drug Administration Staff. Issued December 2015.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Bifeng Qian
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-2261
  Bifeng.Qian@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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