510(k) K000652
K000652 is an FDA 510(k) premarket notification submitted by Betel Care Sdn. Bhd. for the device "BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)". The FDA issued a decision of Substantially Equivalent on Apr 10, 2000. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Betel Care Sdn. Bhd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 2000
- Date Received
- Feb 28, 2000
- 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
- 510(k)
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.