OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED
FDA 510(k) clearance K980421 · decided 1998-03-13
Clearance details
- K-number
- K980421
- Device name
- OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED
- Applicant
- Omnigrace (Thailand) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-03
- Decision date
- 1998-03-13
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- North Canton, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.