The following data is part of a premarket notification filed by Kanam Latex Industries Pvt. Ltd. with the FDA for Surgicare Sterile Surgical Gloves.
| Device ID | K904972 |
| 510k Number | K904972 |
| Device Name: | SURGICARE STERILE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | KANAM LATEX INDUSTRIES PVT. LTD. OOPPOOTTIL BUILDING P.O. BOX #28K.K. ROAD Kottayam, Kerala, IN 686001 |
| Contact | Ravi Abraham |
| Correspondent | Ravi Abraham KANAM LATEX INDUSTRIES PVT. LTD. OOPPOOTTIL BUILDING P.O. BOX #28K.K. ROAD Kottayam, Kerala, IN 686001 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1991-01-31 |