510(k) K101630
K101630 is an FDA 510(k) premarket notification submitted by Pt. Smartglove Indonesia for the device "POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE". The FDA issued a decision of Substantially Equivalent on Sep 7, 2010. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Pt. Smartglove Indonesia has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 7, 2010
- Date Received
- Jun 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Polymer Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
- 510(k)
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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.