Submission Details
| 510(k) Number | K221718 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 13, 2022 |
| Decision Date | September 24, 2022 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
Sep 2022
Decision
103d
Days
Class 1
Risk
About This 510(k) Submission
K221718 is an FDA 510(k) clearance for the Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural), a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on September 24, 2022, 103 days after receiving the submission on June 13, 2022. 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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