NITRILE POWDER FREE EXAMINATION GLOVES
FDA 510(k) clearance K983334 · decided 1999-02-19
Clearance details
- K-number
- K983334
- Device name
- NITRILE POWDER FREE EXAMINATION GLOVES
- Applicant
- Cranberry (M) Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-23
- Decision date
- 1999-02-19
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ipoh Perak, MY
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cranberry (M) Sdn. Bhd.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.