Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
FDA 510(k) clearance K243959 · decided 2025-02-24
Clearance details
- K-number
- K243959
- Device name
- Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
- Applicant
- Lingshi Hongruida Health Protection Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-23
- Decision date
- 2025-02-24
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Jinzhong, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lingshi Hongruida Health Protection Technology Co.
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.