POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
FDA 510(k) clearance K014077 · decided 2002-02-04
Clearance details
- K-number
- K014077
- Device name
- POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
- Applicant
- Shijiazhuang Great Vision Plastic Products Co., LT
- Decision
- Substantially Equivalent
- Date received
- 2001-12-11
- Decision date
- 2002-02-04
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Chino, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.