510(k) K161932
K161932 is an FDA 510(k) premarket notification submitted by Terang Nusa Sdn Bhd for the device "Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink". The FDA issued a decision of Substantially Equivalent on Nov 28, 2016. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Terang Nusa Sdn Bhd has 25 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 28, 2016
- Date Received
- Jul 14, 2016
- 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.