Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves
K001834 is the FDA 510(k) clearance record for SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES, a class I device, cleared for Shijiazhuang Hongxiang Plastics Products Co; , Ltd. 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 9 510(k) clearances for Shijiazhuang Hongxiang Plastics Products Co; , Ltd., from to . As of , FDA records show no recalls naming K001834.
Clearance record
- Decision date
- Received
- (14 days to decision)
- Product code
- LYZ Vinyl Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Shijiazhuang Hongxiang Plastics Products Co; , Ltd. 12390 E. End Ave., Chino CA
- 510(k) summary
- Summary
- 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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