The following data is part of a premarket notification filed by Perlink Usa, Inc. with the FDA for Sterling Powder Free Patient Examination Gloves.
| Device ID | K922358 |
| 510k Number | K922358 |
| Device Name: | STERLING POWDER FREE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
| Contact | Sushil K Kanwar |
| Correspondent | Sushil K 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 | 1992-05-19 |
| Decision Date | 1993-06-11 |