The following data is part of a premarket notification filed by Molnlycke Health Care, Inc. with the FDA for Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene Sterile Examination Glove.
| Device ID | K062138 |
| 510k Number | K062138 |
| Device Name: | POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | MOLNLYCKE HEALTH CARE, INC. 5550 PEACHTREE PKWY STE 500 Norcross, GA 30092 |
| Contact | Steve Dowdley |
| Correspondent | Steve Dowdley MOLNLYCKE HEALTH CARE, INC. 5550 PEACHTREE PKWY STE 500 Norcross, GA 30092 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-26 |
| Decision Date | 2006-10-05 |
| Summary: | summary |