Powder-Free Nitrile Examination Gloves with Aloe Vera, Green (Tested for Use with Chemotherapy Drugs)
K010097 is the FDA 510(k) clearance record for POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS), a class I device, cleared for Shen Wei (Usa), Inc. 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 58 510(k) clearances for Shen Wei (Usa), Inc., from to . As of , FDA records show no recalls naming K010097.
Clearance record
- Decision date
- Received
- (78 days to decision)
- Product code
- LZA Polymer Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Shen Wei (Usa), Inc. 2845 Whipple Rd., Union City CA
- 510(k) summary
- Statement
- 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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