510(k) K201390
K201390 is an FDA 510(k) premarket notification submitted by Medline Industires, Inc. for the device "Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)". The FDA issued a decision of Substantially Equivalent on September 18, 2020. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Medline Industires, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2020
- Date Received
- May 27, 2020
- Clearance Type
- Traditional
- 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.