Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
K230875 is the FDA 510(k) clearance record for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims, a class I device, cleared for Central Medicare Sdn Bhd 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 15 510(k) clearances for Central Medicare Sdn Bhd, from to . As of , FDA records show no recalls naming K230875.
Clearance record
- Decision date
- Received
- (112 days to decision)
- Product code
- LZA Polymer Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Central Medicare Sdn Bhd Pt 2609 - 2620, Batu 8, Jalan Changkat Jong, Teluk Intan, MY
- 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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
