The following data is part of a premarket notification filed by Dawin Investments Ltd. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892788 |
| 510k Number | K892788 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | DAWIN INVESTMENTS LTD. 3/F, SINGGA COMMERCIAL CENTRE, 144-151 Connaught Rd. West, HK |
| Contact | David C Reiner |
| Correspondent | David C Reiner DAWIN INVESTMENTS LTD. 3/F, SINGGA COMMERCIAL CENTRE, 144-151 Connaught Rd. West, HK |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-08-01 |