Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k) clearance K193555 · decided 2020-06-04
Clearance details
- K-number
- K193555
- Device name
- Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Ever Global (Vietnam) Enterprise Corp
- Decision
- Substantially Equivalent
- Date received
- 2019-12-20
- Decision date
- 2020-06-04
- Days to decision
- 167 days
- Clearance type
- Abbreviated
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dong Nai Province, VN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.