BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
FDA 510(k) clearance K992337 · decided 1999-08-17
Clearance details
- K-number
- K992337
- Device name
- BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
- Applicant
- Mexpo Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-13
- Decision date
- 1999-08-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FMC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hayward,, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.