Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color
K030094 is the FDA 510(k) clearance record for DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR, a class I device, cleared for Shanghai Palomar Mountain Industries, Inc. on under FDA product code LYZ (Vinyl Patient Examination Glove). FDA's definition for product code LYZ reads: "A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 provide a barrier against...". FDA records list 12 510(k) clearances for Shanghai Palomar Mountain Industries, Inc., from to . As of , FDA records show no recalls naming K030094.
Clearance record
- Decision date
- Received
- (81 days to decision)
- Product code
- LYZ Vinyl Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Shanghai Palomar Mountain Industries, Inc. 18709 Greenbay Dr., Rowland Heights CA
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code LYZ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 1 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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