The following data is part of a premarket notification filed by Hindustan Latex Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K923592 |
| 510k Number | K923592 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | HINDUSTAN LATEX LTD. 3030 ANTLER DR. Doylestown, PA 18901 |
| Contact | James R Collie |
| Correspondent | James R Collie HINDUSTAN LATEX LTD. 3030 ANTLER DR. Doylestown, PA 18901 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-20 |
| Decision Date | 1992-10-28 |