The following data is part of a premarket notification filed by M/s. Kanam Latex Industries Pvt. Ltd. with the FDA for Powder Free Latex Sterile Patient Examination Gloves.
| Device ID | K052728 |
| 510k Number | K052728 |
| Device Name: | POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | M/S. KANAM LATEX INDUSTRIES PVT. LTD. OOPPOOTTIL BUILDINGS, K.K.ROAD Kottayam, Kerala, IN 686001 |
| Contact | Ravi Abraham |
| Correspondent | Ravi Abraham M/S. KANAM LATEX INDUSTRIES PVT. LTD. OOPPOOTTIL BUILDINGS, K.K.ROAD Kottayam, Kerala, IN 686001 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2005-12-05 |