The following data is part of a premarket notification filed by Marcon Rubber Industry Sdn. Bhd. with the FDA for Patient Examination Glove.
| Device ID | K890591 |
| 510k Number | K890591 |
| Device Name: | PATIENT EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | MARCON RUBBER INDUSTRY SDN. BHD. 6800 LINDBERGH BLVD. Philadelphia, PA 19142 |
| Contact | George C Evanson |
| Correspondent | George C Evanson MARCON RUBBER INDUSTRY SDN. BHD. 6800 LINDBERGH BLVD. Philadelphia, PA 19142 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09555697506294 | K890591 | 000 |
| 09555697506287 | K890591 | 000 |
| 09551023920017 | K890591 | 000 |
| 09551023920000 | K890591 | 000 |
| 09551023920048 | K890591 | 000 |
| 09551023920031 | K890591 | 000 |
| 09551023920024 | K890591 | 000 |