The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Powdred Hypoallergenic Steril Surg Gloves.
| Device ID | K894354 |
| 510k Number | K894354 |
| Device Name: | SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | SAFESKIN CORP. 1701 PONCE DE LEON BLVD. Coral Gables, FL 33134 |
| Contact | Jeanne D Braverman |
| Correspondent | Jeanne D Braverman SAFESKIN CORP. 1701 PONCE DE LEON BLVD. Coral Gables, FL 33134 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-08-23 |