510(k) K934133
K934133 is an FDA 510(k) premarket notification submitted by Supergrade Healthcare Products Sdn. Bhd. for the device "PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Supergrade Healthcare Products Sdn. Bhd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1994
- Date Received
- August 18, 1993
- 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.