Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
FDA 510(k) clearance K162924 · decided 2017-01-24
Clearance details
- K-number
- K162924
- Device name
- Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
- Applicant
- Hartalega Sdb. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-18
- Decision date
- 2017-01-24
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bandar Sri Damansara, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.