510(k) K211667
K211667 is an FDA 510(k) premarket notification submitted by Changzhou Universal Medical Equipment Co., Ltd. for the device "Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)". The FDA issued a decision of Substantially Equivalent on September 23, 2021. The device falls under product code LAZ (N-Acetylprocainamide Control Materials), a Class I device regulated under 21 CFR 862.3280. Changzhou Universal Medical Equipment Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2021
- Date Received
- June 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- N-Acetylprocainamide Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type