510(k) K011728
K011728 is an FDA 510(k) premarket notification submitted by Brightway Holdings Sdn. Bhd. for the device "BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (". The FDA issued a decision of Substantially Equivalent on Jul 9, 2001. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Brightway Holdings Sdn. Bhd. has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 9, 2001
- Date Received
- Jun 4, 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.