510(k) K211714
K211714 is an FDA 510(k) premarket notification submitted by Hengchang (Dongying) Medical Technology Co., Ltd. for the device "Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)". The FDA issued a decision of Substantially Equivalent on Aug 4, 2021. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Hengchang (Dongying) Medical Technology Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 2021
- Date Received
- Jun 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
- 510(k)
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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.