Clearance Summary
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink received FDA 510(k) clearance under submission number K161932, sponsored by Terang Nusa Sdn Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-11-28.
- Submission: K161932
- Applicant / Sponsor: Terang Nusa Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2016-11-28
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.