The following data is part of a premarket notification filed by Kanam Latex Industries Pvt. Ltd. with the FDA for Powder Free Latex Surgeons Gloves Polymer Coated Sterile With Optional Labeling Claim Of E.p. Less Than 50 Ug/dm2.
| Device ID | K033564 |
| 510k Number | K033564 |
| Device Name: | POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2 |
| Classification | Surgeon's Gloves |
| Applicant | KANAM LATEX INDUSTRIES PVT. LTD. OPPOOTTIL BUILDING P.O. BOX #28 K.K.ROAD Kottayam, Kerala, IN 686001 |
| Contact | Ravi Abraham |
| Correspondent | Ravi Abraham KANAM LATEX INDUSTRIES PVT. LTD. OPPOOTTIL BUILDING P.O. BOX #28 K.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 | 2003-11-12 |
| Decision Date | 2004-02-24 |