510(k) K211758
K211758 is an FDA 510(k) premarket notification submitted by Hartalega NGC Sdn. Bhd. for the device "Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)". The FDA issued a decision of Substantially Equivalent on August 3, 2021. The device falls under product code OPC (Powder-Free Polychloroprene Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Hartalega NGC Sdn. Bhd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 2021
- Date Received
- June 7, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder-Free Polychloroprene Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.