Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves
K102089 is the FDA 510(k) clearance record for GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES, a class I device, cleared for Grand Work Plastic 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 19 510(k) clearances for Grand Work Plastic Products Co., Ltd., from to . As of , FDA records show no recalls naming K102089.
Clearance record
- Decision date
- Received
- (62 days to decision)
- Product code
- LYZ Vinyl Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Zanhuang County, CN
- 510(k) summary
- Summary PDF
- 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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