510(k) K231029
K231029 is an FDA 510(k) premarket notification submitted by Zhonghong Pulin Medical Products Co., Ltd. for the device "Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl". The FDA issued a decision of Substantially Equivalent on October 30, 2023. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Zhonghong Pulin Medical Products Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2023
- Date Received
- April 11, 2023
- Clearance Type
- Traditional
- 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.