International Organization for
Sr. No PPE Item
Standardization
1 Gloves ISO 374-5:2016
Shoe Cover
2 ISO 20345:2011
Protective
Clothing : ISO 16603:2004
3
Coveralls/Gowns/ ISO 13688:2013
Head Covers
ISO 22612:2005 , ISO 16603 ,
4 N-95 Masks
ISO 22609:2004
Three Layer
5 Masks ISO 22612:2005 , ISO 16603
In the U.S., PPE is generally regulated by the U.S. Food
and Drug Administration (FDA) as medical devices.
NOTE Therefore, manufacturers must comply with medical
device regulations, which include the FDA's rules on
importation of devices
American Society for Testing and American National
Standard for Bureau of Indian Standards
Materials Personal Protection
ASTM D6319-10 IS 4148 : 1989
ASTM D3577 - 19 ANSI/SEA 105-2011 IS 13422 : 1992
IS 15354 : Part 1 : 2018
IS 15298 : Part 1 : 2015
IS 15298 : Part 2 : 2016
ASTM F2412-05 ANSI Z41-1999 IS 15298 : Part 3 : 2019
IS 15298 : part 4 : 2017
ASTM F2407 - 06(2013)e1
ASTM F1671 / F1671M - 13
ASTM F1868 - 17
ASTM D751 - 19
ASTM D1776/D1776M-20 ANSI/ISEA 101-2014 IS 17334 : 2019
ASTM D5034-09(2017)
ASTM D6701-16
ASTM D5587-15(2019)
ASTM F1494-14
ASTM F1862 IS 9473:2002
ASTM F2100 - 19 , ASTM F 1215-89 IS 16289 : 2014
British Standards Institution DIN Standards, Germany Regulation EC & UK
DIN EN 455-1:2001-01
BS EN 455-1:2000 DIN EN 455-2:2015-07
BS EN 455-2:2015 DIN EN 455-3:2015-07
BS EN 455-3:2015 DIN EN 455-4:2009-10 (EU) 2016/425
BS EN 455-4:2009 DIN EN 420:2010-03
BS EN ISO 374-5:2016 DIN EN ISO 374-1:2018-10
DIN EN ISO 374-5:2017-03
BS EN ISO 20345:2011 None (EU) 2016/425
BS EN 13795-1:2019 S DIN EN 14126:2004-01
BS EN 13795-2:2019 S DIN EN 14605:2009-08
BS EN 14126:2003 DIN EN ISO 13688:2013-12 (EU) 2016/425
BS EN 14605:2009+A1:2009 DIN EN 13795-1:2019-06
BS EN ISO 13688:2013 DIN EN 13795-2:2019-06
BS EN 140:1999, BS EN 149:2001
DIN EN 149:2009-08 (EU) 2016/425
+A1:2009
EN 14683:2019+AC:2019 DIN EN 14683:2019-10 (EU) 2016/425
Regulation US Other Relevant Info
Current good manufacturing practices
(CGMP’s) by FDA
29 CFR 1910.1030 Bloodborne pathogens
Specifications:
-Nitrile
-Non-sterile
-Powder free
https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/importing-covid-19-supplies
-Outer gloves preferably reachmid-
forearm (minimum 280
mmtotallength)
-Different sizes (6.5 &7)
Coveralls usually cover the head and
all these items follow the same
https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/importing-covid-19-supplies
standards and thus kept in the same
category of protective clothing
https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/importing-covid-19-supplies
21 CFR 878.4040
42 CFR Part 84
PPE Item Standard
ISO 374-5:2016(en)
ASTM D6319 - 19
ASTM D3577 - 19
ANSI/SEA 105-2011
IS 4148 : 1989
IS 13422 : 1992
IS 15354 : Part 1 : 2018
BS EN 455-1:2000
BS EN 455-2:2015
Gloves BS EN 455-3:2015
BS EN 455-4:2009
BS EN ISO 374-5:2016
DIN EN 455-1:2001-01
DIN EN 455-2:2015-07
DIN EN 455-3:2015-07
DIN EN 455-4:2009-10
DIN EN 420:2010-03
DIN EN ISO 374-1:2018-10
DIN EN ISO 374-5:2017-03
ISO 20345:2011
ASTM F2412-05
ANSI Z41-1999
Shoe Cover IS 15298 : Part 1 : 2015
IS 15298 : Part 2 : 2016
IS 15298 : Part 3 : 2019
IS 15298 : part 4 : 2017
BS EN ISO 20345:2011
ASTM F2407 - 06(2013)e1
ASTM F1671 / F1671M - 13
ASTM F1868 - 17
ASTM D751 - 19
ASTM D1776/D1776M-20
ASTM D5034-09(2017)
ASTM D6701-16
ASTM D5587-15(2019)
ASTM F1494-14
Protective Clothing : BS EN 13795-1:2019 S
Coveralls/Gowns/Head
Covers BS EN 13795-2:2019 S
BS EN 14126:2003
Protective Clothing :
Coveralls/Gowns/Head
Covers
BS EN 14605:2009+A1:2009
BS EN ISO 13688:2013
DIN EN 14126:2004-01
DIN EN 14605:2009-08
DIN EN ISO 13688:2013-12
DIN EN 13795-1:2019-06
DIN EN 13795-2:2019-06
IS 9473:2002
IS 16289 : 2014
ASTM F1862
ASTM F2100 - 19
ASTM F2101 - 19
ASTM F2299
N95 & Three Layer Masks
DIN EN 149:2009-08
DIN EN 14683:2019-10
BS EN 14683
BS EN 140:1999
BS EN 149:2001
EN 149
EN 14683:2019+AC:2019
Title
Protective gloves against dangerous chemicals and micro-organisms — Part 5: Terminology and performance requir
Standard Specification for Nitrile Examination Gloves for Medical Application
Standard Specification for Rubber Surgical Gloves
Hand Protection Classification
Surgical Rubber Gloves - Specification
Disposable surgical rubber gloves - Specification
Single-Use Medical Examination Gloves - Part 1 Specification for Gloves Made from Rubber Latex or Rubber Solution
Medical gloves for single use. Requirements and testing for freedom from holes
Medical gloves for single use. Requirements and testing for physical properties
Medical gloves for single use. Requirements and testing for biological evaluation
Medical gloves for single use. Requirements and testing for shelf life determination
Protective gloves against dangerous chemicals and micro-organisms. Terminology and performance requirements fo
Medical gloves for single use – Part 1: Requirements and testing for freedom from holes
Medical gloves for single use – Part 2: Requirements and testing for physical properties
Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
Medical gloves for single use – Part 4: Requirements and testing for shelf life determination
Protective gloves - General requirements and test methods
Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance require
Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance require
Personal protective equipment — Safety footwear
Standard Test Methods for Foot Protection
Standard for Foot Protection
Personal Protective Equipment Part 1 Test Methods for Footwear
Personal Protective Equipment Part 2 Test Methods for Footwear
Personal Protective Equipment Part 3 Test Methods for Footwear
Personal Protective Equipment Part 4 Test Methods for Footwear
Personal protective equipment. Safety footwear
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathog
Penetration as a Test System
Standard Practice for Conditioning and Testing Textiles
Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
Standard Test Methods for Coated Fabrics
Standard Terminology Relating to Protective Clothing
Standard Terminology Relating to Protective Clothing
Surgical clothing and drapes. Requirements and test methods. Surgical drapes and gowns
Surgical clothing and drapes. Requirements and test methods. Clean air suits
Protective clothing. Performance requirements and tests methods for protective clothing against infective agents
Protective clothing against liquid chemicals. Performance requirements for clothing with liquid-tight (Type 3) or spra
providing protection to parts of the body only (Types PB [3] and PB [4])
Protective clothing. General requirements
Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spr
providing protection to parts of the body only (Types PB [3] and PB [4])
Protective clothing - General requirements (ISO 13688:2013)
Surgical clothing and drapes - Requirements and test methods – Part 1: Surgical drapes and gowns
Surgical clothing and drapes - Requirements and test methods – Part 2: Clean air suits
Respiratory protective devices – filter
Half masks to protect against particles specification
Medical Textiles — Surgical Face Masks — Specification
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood
Standard Specification for Performance of Materials Used in Medical Face Masks
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials
Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration
Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
Medical face masks - Requirements and test methods
Standard for Surgical Masks
Standard specifies minimum requirements for half masks and quarter masks for use as part of respiratory protective
Filtering half masks to protect against particles. Requirements, testing, marking
Standard providing the minimum requirements for filtering facepieces for protection against particles
This standard UNE EN 14683:2019+AC:2019 Medical face masks - Requirements and test methods
O 374-5:2016)
