| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
|
Date of Entry 05/29/2023
|
|
FR Recognition Number
|
6-496
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| Standard | |
ASTM F739-20
Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact |
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Scope/Abstract1.1 This test method measures the permeation of liquids and gases through protective clothing materials under the condition of continuous contact.
1.2 This test method is designed for use when the test chemical is a gas or a liquid, where the liquid is either volatile (that is, having a vapor pressure greater than 1 mm Hg at 25°C) or soluble in water or another liquid that does not interact with the clothing material.
...
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| All parts related to gaseous chemicals. |
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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.
This standard is recognized in part because:
All parts related to gaseous chemical testing are not applicable because an intended use for protection against gaseous chemicals is outside the scope of the existing personal protective clothing regulations, e.g., 21 CFR 878.4040 (Ref. #1), 21 CFR 878.4370 (Ref. #2), 21 CFR 880.6250 (Ref. #3), 21 CFR 878.4460 (Ref #4). |
|
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
|
| §878.4040 |
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
|
Class 2
|
QPC
|
| §878.4040 |
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
|
Class 2
|
QSO
|
| §878.4370 |
Drape, Surgical
|
Class 2
|
KKX
|
| §878.4370 |
Drape, Surgical, Exempt
|
Class 2
|
PUI
|
| §878.4460 |
Surgeon'S Gloves
|
Class 1
|
KGO
|
| §880.6250 |
Latex Patient Examination Glove
|
Class 1
|
LYY
|
| §880.6250 |
Vinyl Patient Examination Glove
|
Class 1
|
LYZ
|
| §880.6250 |
Polymer Patient Examination Glove
|
Class 1
|
LZA
|
| §880.6250 |
Medical Glove, Specialty
|
Class 1
|
LZC
|
| §880.6250 |
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
|
Class 1
|
OPJ
|
| §880.6250 |
Fentanyl And Other Opioid Protection Glove
|
Class 1
|
QDO
|
|
Relevant FDA Guidance and/or Supportive Publications*
1.) 21 CFR 878.4040, Surgical apparel, May 17 2018.
2.) 21 CFR 878.4371, Surgical drape and drape accessories, Dec 30 2019.
3.) 21 CFR 880.6250, Non-powdered patient examination gloves, Dec. 30 2019.
4.) 21 CFR 878.4460, Non-powdered surgeon's glove, Dec 19 2016.
5.) Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued August 1993.
6.) Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings, issued December 2015.
7.) Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, issued January 2008.
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
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
