Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label
K083409 is the FDA 510(k) clearance record for POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL, a class I device, cleared for Wrp Asia Pacific Sdn. Bhd. 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 46 510(k) clearances for Wrp Asia Pacific Sdn. Bhd., from to . As of , FDA records show no recalls naming K083409.
Clearance record
- Decision date
- Received
- (253 days to decision)
- Product code
- LZC Medical Glove, Specialty
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Wrp Asia Pacific Sdn. Bhd. Lot 1, Jalan 3,, Salak Tinggi, Sepang Selangor, MY
- 510(k) summary
- Summary PDF
- 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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