The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Purple Powder-free Nitrile Examination Gloves For Use With Chemotherapeutic Drugs Labeling Claim.
| Device ID | K992162 |
| 510k Number | K992162 |
| Device Name: | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM |
| Classification | Patient Examination Glove, Specialty |
| Applicant | SAFESKIN CORP. 12671 HIGH BLUFF DR. San Diego, CA 92130 |
| Contact | Eugene V Goorchenko |
| Correspondent | Eugene V Goorchenko SAFESKIN CORP. 12671 HIGH BLUFF DR. San Diego, CA 92130 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 1999-08-30 |
| Summary: | summary |