POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
FDA 510(k) clearance K032374 · decided 2003-10-22
Clearance details
- K-number
- K032374
- Device name
- POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
- Applicant
- Perusahaan Getah Asas Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-01
- Decision date
- 2003-10-22
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Gambrills, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Glove recall (Z-3114-2011) | Ansell Healthcare Products LLC | 2011-08-31 |
| MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Glov recall (Z-3115-2011) | Ansell Healthcare Products LLC | 2011-08-31 |
| MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination Glove recall (Z-3116-2011) | Ansell Healthcare Products LLC | 2011-08-31 |
| MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examinatio recall (Z-3117-2011) | Ansell Healthcare Products LLC | 2011-08-31 |