POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL
FDA 510(k) clearance K050527 · decided 2005-03-18
Clearance details
- K-number
- K050527
- Device name
- POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL
- Applicant
- Spi Gloves Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-02
- Decision date
- 2005-03-18
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ipoh 30450, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.