The following data is part of a premarket notification filed by O&m Halyard, Inc. with the FDA for Purezero Marin Nitrile Powder-free Exam Gloves, Purezero Marin-xtra Nitrile Powder-free Exam Gloves.
Device ID | K220547 |
510k Number | K220547 |
Device Name: | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves |
Classification | Polymer Patient Examination Glove |
Applicant | O&M Halyard, Inc. 1 Edison Drive Alpharetta, GA 30005 |
Contact | Angela L. Bunn |
Correspondent | Angela L. Bunn O&M Halyard, Inc. 1 Edison Drive Alpharetta, GA 30005 |
Product Code | LZA |
Subsequent Product Code | LZC |
Subsequent Product Code | QDO |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-25 |
Decision Date | 2022-06-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30680651488818 | K220547 | 000 |
30680651487620 | K220547 | 000 |
30680651487637 | K220547 | 000 |
30680651487644 | K220547 | 000 |
30680651487651 | K220547 | 000 |
30680651487668 | K220547 | 000 |
30680651487675 | K220547 | 000 |
30680651487682 | K220547 | 000 |
30680651487699 | K220547 | 000 |
30680651487705 | K220547 | 000 |
30680651488771 | K220547 | 000 |
30680651488788 | K220547 | 000 |
30680651488795 | K220547 | 000 |
30680651488801 | K220547 | 000 |
30680651487613 | K220547 | 000 |