LZC
- Product code
- LZC
- Device name
- Medical Glove, Specialty
- Device class
- Class 1
- 21 CFR
- 21 CFR 880.6250
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 79 (all years; only the last 3 years are listed here)
FDA classification definition
A disposable medical glove (examination or surgeons) 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, these gloves may have specialty claims such as chemotherapy, etc.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252313 | 2026-01-14 | Cardinalhealth | Cardinal Health Nitrile Examination Gloves Extended … | — |
| K243959 | 2025-02-24 | Lingshi Hongruida Health Protection Te… | Powder Free Nitrile Examination Gloves (Violet, Blac… |
Official FDA classification page: LZC
Classification and pathway per current FDA publications. Data from openFDA (CC0).