Dermoaroma Disposable Nitrile Examination Glove
K212716 is the FDA 510(k) clearance record for Dermoaroma Disposable Nitrile Examination Glove, a class I device, cleared for Chuzhou Harmony Gloves Medical Technology Co.,Ltd on under FDA product code LZA (Polymer Patient Examination Glove). FDA's definition for product code LZA reads: "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...". FDA records list one 510(k) clearance for Chuzhou Harmony Gloves Medical Technology Co.,Ltd. As of , FDA records show no recalls naming K212716.
Clearance record
- Decision date
- Received
- (122 days to decision)
- Product code
- LZA Polymer Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Chuzhou Harmony Gloves Medical Technology Co.,Ltd Technology Rd. 6,, Chuzhou, CN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code LZA
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 2 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 5 |
| July 2026 | 2 |
| August 2026 | 1 |
| September 2026 | 4 |
| October 2026 | 1 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
