POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB
FDA 510(k) clearance K030112 · decided 2003-02-27
Clearance details
- K-number
- K030112
- Device name
- POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB
- Applicant
- Pt. Smartglove Indonesia
- Decision
- Substantially Equivalent
- Date received
- 2003-01-13
- Decision date
- 2003-02-27
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tg Morawa-Deli Serdang Utara, ID
- 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.