ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
FDA 510(k) clearance K021007 · decided 2002-07-05
Clearance details
- K-number
- K021007
- Device name
- ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
- Applicant
- Tillotson Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-28
- Decision date
- 2002-07-05
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bedford, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.