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 |