Clearance Summary
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) received FDA 510(k) clearance under submission number K010961, sponsored by Ansell Healthcare Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2001-05-31.
- Submission: K010961
- Applicant / Sponsor: Ansell Healthcare Products, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-05-31
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.