Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
FDA 510(k) clearance K190860 · decided 2019-12-23
Clearance details
- K-number
- K190860
- Device name
- Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
- Applicant
- Ever Growth (Vietnam) Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-02
- Decision date
- 2019-12-23
- Days to decision
- 265 days
- Clearance type
- Abbreviated
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Binhloc Village, VN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.