The following data is part of a premarket notification filed by O&m Halyard, Inc. with the FDA for Purezero Limon Nitrile Powder-free Exam Gloves, Purezero Limon-xtra Nitrile Powder-free Exam Gloves.
| Device ID | K220541 |
| 510k Number | K220541 |
| Device Name: | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-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 |
|---|---|---|
| 30680651488016 | K220541 | 000 |
| 30680651487514 | K220541 | 000 |
| 30680651487521 | K220541 | 000 |
| 30680651487538 | K220541 | 000 |
| 30680651487545 | K220541 | 000 |
| 30680651487972 | K220541 | 000 |
| 30680651487989 | K220541 | 000 |
| 30680651487996 | K220541 | 000 |
| 30680651488009 | K220541 | 000 |
| 30680651487507 | K220541 | 000 |