Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
FDA 510(k) clearance K190403 · decided 2019-09-06
Clearance details
- K-number
- K190403
- Device name
- Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
- Applicant
- Ever Global (Vietnam) Enterprise Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-02-19
- Decision date
- 2019-09-06
- Days to decision
- 199 days
- Clearance type
- Abbreviated
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Long Tanh District, VN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.