510(k) K013498
K013498 is an FDA 510(k) premarket notification submitted by Maxter Glove Manufacturing Sdn Bhd for the device "CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)". The FDA issued a decision of Substantially Equivalent on Jan 17, 2002. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Maxter Glove Manufacturing Sdn Bhd has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 17, 2002
- Date Received
- Oct 22, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Latex Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
- 510(k)
A latex patient examination glove is a disposable device made of natural rubber latex 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.