The following data is part of a premarket notification filed by Adler Industries, Inc. with the FDA for Dermatec+plus(tm)& Ambiderm(tm) Latex Exam Gloves.
| Device ID | K891819 |
| 510k Number | K891819 |
| Device Name: | DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ADLER INDUSTRIES, INC. 652 BROADWAY 5TH FLOOR New York, NY 10012 |
| Contact | Thomas J Ho |
| Correspondent | Thomas J Ho ADLER INDUSTRIES, INC. 652 BROADWAY 5TH FLOOR New York, NY 10012 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-23 |
| Decision Date | 1989-08-09 |