NITRILE GLOVES
FDA 510(k) clearance K970135 · decided 1997-08-25
Clearance details
- K-number
- K970135
- Device name
- NITRILE GLOVES
- Applicant
- Sage Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-15
- Decision date
- 1997-08-25
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Crystal Lake, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sage Products
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.