GLOVES, PROCEDURE
FDA 510(k) clearance K781278 · decided 1978-08-31
Clearance details
- K-number
- K781278
- Device name
- GLOVES, PROCEDURE
- Applicant
- Arbrook Mfg. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-25
- Decision date
- 1978-08-31
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- FMC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Arbrook Mfg. Corp.
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.