Clearance Summary
ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES received FDA 510(k) clearance under submission number K952588, sponsored by Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.. 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 1995-10-12.
- Submission: K952588
- Applicant / Sponsor: Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1995-10-12
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.