The following data is part of a premarket notification filed by Protech Industries Co., Ltd. with the FDA for Latex Examination Gloves.
| Device ID | K894473 |
| 510k Number | K894473 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PROTECH INDUSTRIES CO., LTD. 56 WESTCOTT RD. Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky PROTECH INDUSTRIES CO., LTD. 56 WESTCOTT RD. Stamford, CT 06902 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1989-08-21 |