510(k) K213048
K213048 is an FDA 510(k) premarket notification submitted by Huayuan Medical Technology(Shangqiu) Co., Ltd. for the device "Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)". The FDA issued a decision of Substantially Equivalent on Dec 18, 2021. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Huayuan Medical Technology(Shangqiu) Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 18, 2021
- Date Received
- Sep 22, 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.