The following data is part of a premarket notification filed by Perlink Usa, Inc. with the FDA for Disposable Latex Examination Gloves.
| Device ID | K921438 |
| 510k Number | K921438 |
| Device Name: | DISPOSABLE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
| Contact | Kanwar |
| Correspondent | Kanwar PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-25 |
| Decision Date | 1992-06-23 |