Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
FDA 510(k) clearance K211667 · decided 2021-09-23
Clearance details
- K-number
- K211667
- Device name
- Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
- Applicant
- Changzhou Universal Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-01
- Decision date
- 2021-09-23
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- LAZ
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Changzhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 (K851474) | Vygon Corp. | 1985-05-07 |
| ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL (K823127) | Syva Co. | 1982-11-29 |
| EMIT-AND METHOTREXATE CONTROL (K811461) | Syva Co. | 1981-06-09 |
Recalls involving this device
No recalls on record reference this clearance.