Personal Protective Equipment (PPE)

The United States Food and Drug Administration

FDA regulation: 21 CFR 878.4040 Surgical Apparel

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Class II (special controls) for surgical gowns and surgical masks.

A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification 510(k) procedures and the following conditions for exemption:

  •  The user contacting components of the device must be demonstrated to be biocompatible.
  • Analysis and nonclinical testing must:
  1. Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
  2. Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
  • NIOSH approved under its regulation.

Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification 510(k) procedures.

Product Codes Under 21 CFR 878.4040

BWP: Conductive Surgical Shoe And Shoe Cover
FXO: Surgical Suit
FXP: Operating-Room Shoe Cover
FXW: Operating-Room Shoes
FXZ: Surgical Helmet
FYE: Surgical Dress
FYF: Surgical Cap
LYU: Surgical Apparel Accessory
OEA: Non-Surgical Isolation Gown

Product Code: OEA – FDA 510(k) Exempt

A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material. An isolation gown is made of fabric material, either non-woven or woven and it covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material.  

An isolation gown serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific.

Body Measurements in Centimeters (CM) and Inches

Source: DuPont

The European Union (EU)

CE Mark

Personal protective equipment (PPE) refers to products that the user can wear or hold, to be protected against risks either at work, at home or whilst engaging in leisure activities.

PPE must be CE marked by the manufacturer before being sold in
Europe (the European Economic Area).

To obtain CE mark, PPE is subject to conformity assessment procedures under a new EU Regulation EU Regulation 2016/425 PPE (“PPE Regulation”) (dated 9 March 2016), which replaces the previous PPE Directive (89/686/EEC) on 21 April 2018. 

The PPE regulation covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.

The PPE Regulation Guidelines (1st edition – April 2018) aim to facilitate a common understanding and implementation of the PPE regulation. 

PPE Categories

  • Category I (simple): As defined under Annex I (see EU Regulation 2016/425), PPE intended to protect users against minimal risks. 
  • Category II (neither simple nor complex):  PPE falling into neither Category I or Category III
  • Category III (complex): As described in Annex I, PPE intended to protect users against very serious risk such as death or irreversible damage to health

Conformity Assessment Routes are shown below. 

 

Source:  BTTG

Chemical Protective Clothing falls under Category III.  

Various criteria apply for protective clothing as briefly summarized below. 

The EU’s harmonized product standards are based on six (6) types defining six levels of protection within chemical protective clothing (Category III). 

Chemical Protection

  • EN 943-1 and EN 943-2 – “Gas-tight” (Type 1) and “non-gas-tight” (Type 2) protective suits
  • EN 14605 – Liquid-tight (Type 3) or spray-tight (Type 4) protective clothing
  • EN ISO 13982 – Protective clothing against solid particulates (Type 5)
    EN 13034 – Limited protective performance against liquid chemicals (Type 6)
  • EN 1073-1 and EN 1073-2 – Protective clothing against radioactive contamination
  • EN 14126 – Protective clothing against infective agents
  • EN 374 – Protective gloves against chemicals and micro-organisms

Other Applicable, Relevant Standards 

Source: DuPont

Last Updated: 2020-07-10

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