Submission Details
| 510(k) Number | K203538 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 2020 |
| Decision Date | August 02, 2021 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
Aug 2021
Decision
242d
Days
Class 1
Risk
About This 510(k) Submission
K203538 is an FDA 510(k) clearance for the SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs), a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on August 2, 2021, 242 days after receiving the submission on December 3, 2020. 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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