The following data is part of a premarket notification filed by Unidus Corp. with the FDA for Skin Angel Brand (patient Exam Gloves - Latex).
| Device ID | K891854 |
| 510k Number | K891854 |
| Device Name: | SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | UNIDUS CORP. ROOM 705, KEOYANG BLDG. 51-8 SOOSONG-DONG, CHONGRO-KU Seoul, Korea, KR |
| Contact | Choi, Hyungjin |
| Correspondent | Choi, Hyungjin UNIDUS CORP. ROOM 705, KEOYANG BLDG. 51-8 SOOSONG-DONG, CHONGRO-KU Seoul, Korea, KR |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-04-11 |