The following data is part of a premarket notification filed by Hope Rubber Industrial Corp. with the FDA for Patient Examination Gloves.
| Device ID | K893056 |
| 510k Number | K893056 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | HOPE RUBBER INDUSTRIAL CORP. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz HOPE RUBBER INDUSTRIAL CORP. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-06-09 |