Submission Details
| 510(k) Number | K040503 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 27, 2004 |
| Decision Date | March 16, 2004 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
Mar 2004
Decision
18d
Days
Class 1
Risk
About This 510(k) Submission
K040503 is an FDA 510(k) clearance for the ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on March 16, 2004, 18 days after receiving the submission on February 27, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.
Device Classification
| Product Code | KGO — Surgeon's Gloves |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4460 |
| Definition | A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |
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