510(k) K213937
K213937 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution". The FDA issued a decision of Substantially Equivalent on August 16, 2022. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. O&M Halyard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2022
- Date Received
- December 16, 2021
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.