Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile
K042805 is the FDA 510(k) clearance record for POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE, a class I device, cleared for Perusahaan Getah Asas 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 30 510(k) clearances for Perusahaan Getah Asas Sdn. Bhd., from to . As of , FDA records show no recalls naming K042805.
Clearance record
- Decision date
- Received
- (65 days to decision)
- Product code
- LZC Medical Glove, Specialty
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Perusahaan Getah Asas Sdn. Bhd. Lot 754, Jalan Haji Sirat, Klang, 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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