510(k) K982897
K982897 is an FDA 510(k) premarket notification submitted by Pt. Maja Agung Latexindo for the device "POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)". The FDA issued a decision of Substantially Equivalent on Dec 23, 1998. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Pt. Maja Agung Latexindo has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 23, 1998
- Date Received
- Aug 17, 1998
- 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.