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21 CFR: What Does It Mean for PPE?

Food Processing Operators Wearing PPEAs consumers of food, we put our trust in food processors that they equip their workers with the proper supplies needed to keep our food safe for consumption.

Cross contamination of one item or surface onto another can cause serious health illnesses or allergeric reactions. For example, many workers who handle food are most likely to wear non-latex type gloves as latex proteins could be transferred to the food item. If a person has a latex allergy and consumes this tainted food item, the result could be in a serious medical emergency.

To ensure safety, food processors and food service personnel receive guidance from the Food & Drug Administration.  The Food & Drug Administration (FDA) controls all the regulations related to items that are added to food (i.e. direct additives) and items that may come in contact with food (i.e. indirect additives). Title 21 of the CFR is reserved for rules of the Food and Drug Administration. All gloves, apart from medical/exam type disposables are referenced in 21 CFR Parts 174 & 177 when used in food handling applications.


For our purposes, we only really need to concern ourselves with Parts 174 and 177. Before going further, it is important to clearly state that 21-CFR does not call out items such as “gloves”. The regulations reference only the raw materials that make up the “Components of a Food Contact Article”. Clearly, gloves, or sleeves for that matter, are often used as food contact articles. Part 174 references these articles as Indirect Food Additives. They are defined more clearly as: “Items that come into contact with food as part of packaging, holding, or processing, but are not intended to be added directly to, become a component, or have a technical effect in or on the food.”


Part 177 outlines the specifications related to the item classified as “Polymers”. What do gloves, or sleeves have to do with polymers? Simple, any gloves and sleeves that is recommended for food contact are synthetic and polymer-based — both the yarn and coating. So, when there is a  claim that a glove meets 21-CFR-177, it means that the raw material manufacturer of the yarn and, if coated, the resin manufacturer of the coating, meets the very detailed specifications outlined by FDA 21-CFR-177.

Ok, so we’ve established that the 21 CFR part 174 and part 177 are clearly about what is defined as “Indirect Food Additives” and the specifications of the raw materials used in producing PPE such as gloves or sleeves that come in contact with food during the manufacturing or handling process.


We consider that there are three types of food contact:

  1. Direct contact substances are those that directly contact food.
  2. Substances that might come in contact with food, such as on the outside of food bag or carton, are defined as indirect contact.
  3. Incidental food contact are items that rarely contact food and the contact is not purposeful or continuous. For example, food that contacts an extraneous part of a food processing machine, where contact is not expected, is considered incidental.

It is important to consider the specific application when recommending alternatives. For example, while it's technically possible to use  palm coated seamless knit type glove, which is classified as meeting 21-CFR-177, to debone an item such as meat or poultry, it is unlikely a butcher would opt for a black coated glove. Rather, a more common practice is to use an uncoated, high cut resistant glove and overlay or underlay with disposable gloves for maximum protection, impermeability, and hygiene. Whatever the glove, be sure that the glove that contacts the surface complies with the FDA 21 CFR, Part 177 standard.

Below is a guide to help you find the optimal 21-CFR glove or sleeve for the job:
  • Direct Contact in Food Processing for handling, mixing and preparing foods: Polymer Gloves
  • Direct Contact in Food Processing for butchering meats, de-boning fish or slicing vegetables (can be laundered and sanitized): High Cut Resistant Uncoated Knit Glove
  • Direct Contact in Food Processing for butchering meats, de-boning fish or slicing vegetables (can be laundered and sanitized): High Cut Resistant Sleeves
  • Direct Contact in Food Processing and Food Service: Powder Free Disposable Gloves
  • Indirect Contact in Food Plants for MRO applications or sorting and boxing packaged food: Coat Seamless Knit General-Purpose Gloves
  • Indirect Contact in Food Plants – for MRO applications or sorting and boxing glass packaged food: Coat Seamless Knit Cut Resistant Gloves

From single-use to cut-resistant seamless knit gloves to bouffant caps and sleeve protectors, MDS sells a full line of FDA compliant PPE with a heavy emphasis on hand protection. Contact MDS with your requirements or preferred glove style today, or you can hit the button and

+browse our Food Compliant Gloves here now

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