The following data is part of a premarket notification filed by Kanam Latex Industries Pvt. Ltd. with the FDA for Powderfree Latex Surgeon's Gloves.
| Device ID | K013914 |
| 510k Number | K013914 |
| Device Name: | POWDERFREE LATEX SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | KANAM LATEX INDUSTRIES PVT. LTD. K.K. RD., OOPPOOTTIL BLDGS. P.O. BOX 28 Kottayam, Kerala, IN 686001 |
| Contact | Ravi Abraham |
| Correspondent | Ravi Abraham KANAM LATEX INDUSTRIES PVT. LTD. K.K. RD., OOPPOOTTIL BLDGS. P.O. BOX 28 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 | 2001-11-27 |
| Decision Date | 2002-02-06 |