The following data is part of a premarket notification filed by O & M Halyard, Inc. with the FDA for Halyard Pink Underguard Nitrile Powder-free Exam Glove Tested For Use With Chemotherapy Drugs.
| Device ID | K183132 |
| 510k Number | K183132 |
| Device Name: | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | O & M Halyard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Angela L. Bunn |
| Correspondent | Angela L. Bunn O & M Halyard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651474569 | K183132 | 000 |
| 30680651474552 | K183132 | 000 |
| 30680651474545 | K183132 | 000 |
| 30680651474538 | K183132 | 000 |
| 30680651474521 | K183132 | 000 |