The following data is part of a premarket notification filed by Harbour Health Llc with the FDA for Powder Free Nitrile Examination Glove, Tested For Use With Chemoterapy Drugs (blue).
Device ID | K210944 |
510k Number | K210944 |
Device Name: | Powder Free Nitrile Examination Glove, Tested For Use With Chemoterapy Drugs (Blue) |
Classification | Polymer Patient Examination Glove |
Applicant | Harbour Health LLC 4590 MacArthur Boulevard, Suite 500 Newport Beach, CA 92660 |
Contact | Jared Koenig |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
Product Code | LZA |
Subsequent Product Code | LZC |
Subsequent Product Code | OPJ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2021-03-30 |
Decision Date | 2021-04-29 |