Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
FDA 510(k) clearance K252244 · decided 2025-08-21
Clearance details
- K-number
- K252244
- Device name
- Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
- Applicant
- Ever Global (Vietnam) Enterprise Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-07-18
- Decision date
- 2025-08-21
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Taman Village, VN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ever Global (Vietnam) Enterprise Corporation
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.