mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
FDA 510(k) clearance K190876 · decided 2019-12-02
Clearance details
- K-number
- K190876
- Device name
- mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
- Applicant
- Mercator Medical (Thailand), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-04
- Decision date
- 2019-12-02
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Amphur Rattaphum, TH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.