ABSORBO HP-ABSORBABLE DUSTING POWDER
FDA premarket approval N80535/S009 · decided 1999-07-16
Approval details
- PMA number
- N80535
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABSORBO HP-ABSORBABLE DUSTING POWDER
- Generic name
- Powder, dusting, surgical
- Applicant
- Ingredion Incorporated
- Date received
- 1999-03-19
- Decision date
- 1999-07-16
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- KGP
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Bridgewater, NJ
- Statement
- Approval for revised labeling. The request to replace the warning statement: "WARNING-The Powder Should Be Washed Off Gloves with Sterile Solution Before Treated Gloves Are Used In Surgery," with the statement: "Caution: After donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method," is acceptable.
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