Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K101822 is the FDA 510(k) clearance record for NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS, a class I device, cleared for Sgmp Co., Ltd. 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 29 510(k) clearances for Sgmp Co., Ltd., from to . As of , FDA records show no recalls naming K101822.
Clearance record
- Decision date
- Received
- (142 days to decision)
- Product code
- LZC Medical Glove, Specialty
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Sgmp Co., Ltd. 198 Ave. De La D'Emerald, Sparks NV
- 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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