Clearance Summary
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE received FDA 510(k) clearance under submission number K162626, sponsored by Top Quality Glove 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 2017-03-31.
- Submission: K162626
- Applicant / Sponsor: Top Quality Glove Sdn. Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2017-03-31
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.