The following data is part of a premarket notification filed by Tomarc (m) Sdn Bhd with the FDA for Sterile Latex Surgical Glove.
| Device ID | K892899 |
| 510k Number | K892899 |
| Device Name: | STERILE LATEX SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | TOMARC (M) SDN BHD P.O. BOX 4571 Rockville, MD 20850 |
| Contact | L Konopko,pd |
| Correspondent | L Konopko,pd TOMARC (M) SDN BHD P.O. BOX 4571 Rockville, MD 20850 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1990-01-17 |