The following data is part of a premarket notification filed by Asian Latex, Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K910442 |
| 510k Number | K910442 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ASIAN LATEX, LTD. YOGESHWAR M-2, CONNAUGHT PLACE NEW DELHI-110 001 India, IN |
| Contact | Dhiraj Narang |
| Correspondent | Dhiraj Narang ASIAN LATEX, LTD. YOGESHWAR M-2, CONNAUGHT PLACE NEW DELHI-110 001 India, IN |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-31 |
| Decision Date | 1991-02-12 |