LATEX SURGICAL GLOVES, PRE-POWDERED
FDA 510(k) clearance K993450 · decided 1999-12-29
Clearance details
- K-number
- K993450
- Device name
- LATEX SURGICAL GLOVES, PRE-POWDERED
- Applicant
- Fitco Dipped Products Pvt., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-12
- Decision date
- 1999-12-29
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kerala, IN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fitco Dipped Products Pvt.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.