TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
FDA 510(k) clearance K000555 · decided 2000-04-12
Clearance details
- K-number
- K000555
- Device name
- TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
- Applicant
- Tekmedic (M) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2000-02-18
- Decision date
- 2000-04-12
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Alexandria, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.