The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Sterile Examination Gloves, Hypo-allergenic'.
| Device ID | K895807 |
| 510k Number | K895807 |
| Device Name: | STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' |
| Classification | Latex Patient Examination Glove |
| Applicant | SAFESKIN CORP. 1701 PONCE DE LEON BLVD. Coral Gables, FL 33134 |
| Contact | D Braverman |
| Correspondent | D Braverman SAFESKIN CORP. 1701 PONCE DE LEON BLVD. Coral Gables, FL 33134 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-29 |
| Decision Date | 1989-12-18 |