510(k) K791805
K791805 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR EXAM. GLOVES, POLYETHYLENE". The FDA issued a decision of Substantially Equivalent on Oct 1, 1979. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 1, 1979
- Date Received
- Sep 13, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
- 510(k)