510(k) K222498
K222498 is an FDA 510(k) premarket notification submitted by Humanwell Healthcare Group Medical Supplies Co., Ltd. for the device "Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)". The FDA issued a decision of Substantially Equivalent on Oct 26, 2022. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 26, 2022
- Date Received
- Aug 18, 2022
- 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.