Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
K220353 is the FDA 510(k) clearance record for Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs, a class I device, cleared for Niujian Technology Co., Ltd. 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 3 510(k) clearances for Niujian Technology Co., Ltd., from to . As of , FDA records show no recalls naming K220353.
Clearance record
- Decision date
- Received
- (51 days to decision)
- Product code
- LZC Medical Glove, Specialty
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Niujian Technology Co., Ltd. Rm. 401, Bldg. 1, Anfangcheng, #919, E. Qunxian Rd., Shaoxing, CN
- 510(k) summary
- Statement
- 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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