510(k) K200633
K200633 is an FDA 510(k) premarket notification submitted by 0 & M Halyard, Inc. for the device "Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove". The FDA issued a decision of Substantially Equivalent on October 11, 2020. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2020
- Date Received
- March 10, 2020
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medical Glove, Specialty
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.