Patient Nitrile Examination Gloves (Powdered)
K992675 is the FDA 510(k) clearance record for PATIENT NITRILE EXAMINATION GLOVES (POWDERED), a class I device, cleared for Wear Safe Malaysia 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 14 510(k) clearances for Wear Safe Malaysia Sdn. Bhd., from to . As of , FDA records show no recalls naming K992675.
Clearance record
- Decision date
- Received
- (163 days to decision)
- Product code
- LZA Polymer Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Wear Safe Malaysia Sdn. Bhd. Lot 1, Leboh Hishamuddin Satu,, Port Klang, Selangor, D.E., 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 |
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