The following data is part of a premarket notification filed by Kanam Latex Industries Pvt. Ltd. with the FDA for Latex Patient Examination Gloves.
| Device ID | K897139 |
| 510k Number | K897139 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | KANAM LATEX INDUSTRIES PVT. LTD. RR 1, BOX 448 Raphine, VA 24472 |
| Contact | F Veldhuyzen |
| Correspondent | F Veldhuyzen KANAM LATEX INDUSTRIES PVT. LTD. RR 1, BOX 448 Raphine, VA 24472 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-01-23 |