510(k) K190632
K190632 is an FDA 510(k) premarket notification submitted by Lenora Glove Pvt , Ltd. for the device "Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein". The FDA issued a decision of Substantially Equivalent on Oct 24, 2019. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 24, 2019
- Date Received
- Mar 12, 2019
- Clearance Type
- Abbreviated
- 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.