RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
FDA 510(k) clearance K100603 · decided 2010-07-16
Clearance details
- K-number
- K100603
- Device name
- RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
- Applicant
- Riverstone Resources Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2010-03-03
- Decision date
- 2010-07-16
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Selangor, MY
- Third-party review
- No
- Expedited review
- No
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