510(k) K192328
K192328 is an FDA 510(k) premarket notification submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. for the device "JR.MEDIK Latex Surgeons Gloves Powder Free". The FDA issued a decision of Substantially Equivalent on March 10, 2020. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Jr Engineering & Medical Technologies (M) Sdn. Bhd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2020
- Date Received
- August 27, 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
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.