Powder Free Sterile Latex Exam Radiation Attenuation Gloves
K121811 is the FDA 510(k) clearance record for POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES, a class I device, cleared for Shen Wei (Usa), Inc. on under FDA product code LZC (Medical Glove, Specialty). FDA's definition for product code LZC reads: "A disposable medical glove (examination or surgeon’s) 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...". FDA records list 58 510(k) clearances for Shen Wei (Usa), Inc., from to . As of , FDA records show no recalls naming K121811.
Clearance record
- Decision date
- Received
- (154 days to decision)
- Product code
- LZC Medical Glove, Specialty
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Shen Wei (Usa), Inc. 33278 Central Ave., Union City CA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code LZC
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 1 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
