The following data is part of a premarket notification filed by O & M Haylard, Inc. with the FDA for Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
Device ID | K192241 |
510k Number | K192241 |
Device Name: | Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
Classification | Polymer Patient Examination Glove |
Applicant | O & M Haylard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
Contact | Steven Dowdley |
Correspondent | Steven Dowdley O & M Haylard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
Product Code | LZA |
Subsequent Product Code | LZC |
Subsequent Product Code | QDO |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-19 |
Decision Date | 2020-03-13 |