510(k) K223298
K223298 is an FDA 510(k) premarket notification submitted by Shandong Intco Medical Products Co, Ltd. for the device "Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)". The FDA issued a decision of Substantially Equivalent on February 22, 2023. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Shandong Intco Medical Products Co, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2023
- Date Received
- October 27, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Latex Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.