Understanding Nitrile Medical Gloves
Understanding Nitrile Medical Gloves: Medical Device Class I vs. Class II
Nitrile medical gloves are regulated medical devices, but not all medical gloves are regulated at the same level. The key distinction lies in how the U.S. Food and Drug Administration (FDA) classifies medical devices—and where disposable gloves fall within that system.
Understanding where Class I ends and Class II begins is critical for proper glove selection, compliance, and patient safety.
FDA Medical Device Classification: How Gloves Are Regulated
The FDA classifies medical devices into three categories based on risk to the patient:
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Class I – Low risk, general controls
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Class II – Moderate risk, special controls
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Class III – High risk, life-sustaining devices
Disposable medical gloves fall into Class I or Class II, depending on their intended use.
Class I Medical Devices: Examination Gloves
Non-sterile examination gloves are regulated as Class I medical devices.
What Defines a Class I Exam Glove
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Non-sterile
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Single-use
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Intended for routine medical examination
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Requires FDA registration and listing
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Most exam gloves are 510(k)-exempt, but still regulated
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Must be clearly labeled as “Examination Gloves” or “Exam Grade”
Appropriate Uses (Class I Limit)
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General patient examinations
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Blood draws and injections
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Diagnostic testing
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Dental exams
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Handling bodily fluids where sterility is not required
Where Class I Ends:
The moment a procedure requires a sterile field, invasive surgical technique, or direct contact with open tissue, Class I exam gloves are no longer appropriate.
Class II Medical Devices: Sterile & Surgical Gloves
Sterile gloves and surgical gloves are regulated as Class II medical devices due to their increased risk profile.
What Defines a Class II Glove
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Sterile
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Often packaged in pairs
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Intended for surgical or invasive procedures
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Requires FDA 510(k) clearance
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Subject to additional performance and sterility controls
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Must be labeled as “Sterile” or “Surgical Gloves”
Appropriate Uses (Class II Begins)
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Surgical procedures
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Invasive procedures
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Open wound care
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Catheter insertions
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Procedures requiring aseptic technique
Why the Classification Changes:
Failure of a sterile or surgical glove poses a higher risk of infection, which is why Class II gloves require additional regulatory oversight.
Where the Line Is Drawn: Class I vs. Class II
| Requirement | Class I Exam Gloves | Class II Sterile/Surgical Gloves |
|---|---|---|
| Sterility | Non-sterile | Sterile |
| FDA Device Class | Class I | Class II |
| 510(k) Required | Often exempt | Required |
| Intended Use | Routine exams | Surgical / invasive |
| Packaging | Bulk | Individually paired |
| Risk Level | Low | Moderate |
Simple rule:
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No sterile field → Class I exam gloves
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Sterile or invasive procedure → Class II gloves
Why Labeling Matters
The device class and intended use must be clearly printed on the box. If a glove is not labeled as examination, sterile, or surgical, it must not be used for medical purposes, regardless of material or thickness.
Industrial or food-service nitrile gloves are not medical devices and fall outside FDA medical classification entirely.
Final Takeaway
Nitrile medical gloves are not interchangeable across all medical tasks. Class I examination gloves are designed for routine care, while Class II sterile and surgical gloves are required when sterility and invasive procedures are involved. Understanding where Class I ends and Class II begins ensures compliance, protects patients, and prevents improper glove use.
For properly classified and clearly labeled medical gloves, Inland Empire Safety & Supply supplies exam and sterile nitrile gloves suitable for clinical and procedural environments.
Want to learn more about disposable gloves? Read Are Nitrile Gloves Heat Resistant to discover the heat resistance of nitrile gloves and their applications in various industries. Learn more about disposable nitrile gloves here.