PMA N80535S009

Device: ABSORBO HP-ABSORBABLE DUSTING POWDER
Applicant: Ingredion Incorporated
PMA number: N80535
Supplement: S009
Product code: KGP
Decision date: 1999-07-16
Generic name: Powder, dusting, surgical
Approval order 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.

Current openFDA PMA Record#

Device: ABSORBO HP-ABSORBABLE DUSTING POWDER
Applicant: Ingredion Incorporated
PMA number: N80535
Supplement: S009
Product code: KGP
Generic name: Powder, dusting, surgical
Decision date: 1999-07-16
Decision code: APPR
Date received: 1999-03-19
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.