The following data is part of a premarket notification filed by Care-pro Industries, Inc. with the FDA for Non-sterile Patient Examination Gloves.
| Device ID | K892772 |
| 510k Number | K892772 |
| Device Name: | NON-STERILE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | CARE-PRO INDUSTRIES, INC. 16 GILLMAN ST. Irvine, CA 92715 |
| Contact | Felita R Gonzalez |
| Correspondent | Felita R Gonzalez CARE-PRO INDUSTRIES, INC. 16 GILLMAN ST. Irvine, CA 92715 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-08-04 |