Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
K233182 is the FDA 510(k) clearance record for Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue), a class I device, cleared for Zibo Kaiyue Mould Technology 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 Zibo Kaiyue Mould Technology Co., Ltd. As of , FDA records show no recalls naming K233182.
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
- Zibo Kaiyue Mould Technology Co., Ltd. # 268 Taishan Rd., Guoli Town, Huantai County, Zibo, 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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