POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
FDA 510(k) clearance K072197 · decided 2008-03-12
Clearance details
- K-number
- K072197
- Device name
- POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
- Applicant
- Metacure Surgical Gloves Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2007-08-07
- Decision date
- 2008-03-12
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Petaling Jaya, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.