POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
FDA 510(k) clearance K001327 · decided 2000-05-23
Clearance details
- K-number
- K001327
- Device name
- POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
- Applicant
- Premier Pathway Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-26
- Decision date
- 2000-05-23
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sparks, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.