LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
FDA 510(k) clearance K002448 · decided 2000-09-11
Clearance details
- K-number
- K002448
- Device name
- LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
- Applicant
- Oon Corp. Resources
- Decision
- Substantially Equivalent
- Date received
- 2000-08-09
- Decision date
- 2000-09-11
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seremban, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.