The following data is part of a premarket notification filed by Kanam Latex Industries Pvt. Ltd. with the FDA for Pre-powdered Sterile Exam Gloves.
| Device ID | K052214 |
| 510k Number | K052214 |
| Device Name: | PRE-POWDERED STERILE EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-15 |
| Decision Date | 2005-09-13 |