Non-Sterile, Powder Free Nitrile Examination Gloves, Blue
K122363 is the FDA 510(k) clearance record for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, a class I device, cleared for Siam Sempermed Corp., 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 37 510(k) clearances for Siam Sempermed Corp., Ltd., from to . As of , FDA records show no recalls naming K122363.
Clearance record
- Decision date
- Received
- (35 days to decision)
- Product code
- LZA Polymer Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Siam Sempermed Corp., Ltd. 13900 49th St. N., Clearwater FL
- 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 | 0 |
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