510(k) K213325
K213325 is an FDA 510(k) premarket notification submitted by Anhui Xinyisheng Medical Technology Co.,Ltd for the device "Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on January 28, 2022. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Anhui Xinyisheng Medical Technology Co.,Ltd has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2022
- Date Received
- October 5, 2021
- 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.