NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
FDA 510(k) clearance K052502 · decided 2005-11-18
Clearance details
- K-number
- K052502
- Device name
- NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
- Applicant
- Yty Industry (Manjung) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2005-09-13
- Decision date
- 2005-11-18
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sparks, NV, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.