Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155 is the FDA 510(k) clearance record for Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs, a class I device, cleared for Motex Healthcare (Anhui) 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 Motex Healthcare (Anhui) Co., Ltd. As of , FDA records show no recalls naming K220155.
Clearance record
- Decision date
- Received
- (124 days to decision)
- Product code
- LZA Polymer Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Motex Healthcare (Anhui) Co., Ltd. Xinhang Economic Development Zone, Guangde County, Xuancheng City, CN
- 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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