The following data is part of a premarket notification filed by Amsia Intl., Inc. with the FDA for Rubber Latex Patient Examination Gloves.
| Device ID | K891866 |
| 510k Number | K891866 |
| Device Name: | RUBBER LATEX PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | AMSIA INTL., INC. 117 GRAYSON PLACE Teaneck, NJ 07666 |
| Contact | Jim Lee |
| Correspondent | Jim Lee AMSIA INTL., INC. 117 GRAYSON PLACE Teaneck, NJ 07666 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-04-11 |