510(k) K203538
K203538 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)". The FDA issued a decision of Substantially Equivalent on Aug 2, 2021. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Medline Industries, Inc. has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 2, 2021
- Date Received
- Dec 3, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgeon'S Gloves
- Device Class
- Class I
- Regulation Number
- 878.4460
- Review Panel
- HO
- Submission Type
- 510(k)
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.