The following data is part of a premarket notification filed by Good Glove Corp. with the FDA for Vinyl Examination Gloves (non-sterile).
| Device ID | K894025 |
| 510k Number | K894025 |
| Device Name: | VINYL EXAMINATION GLOVES (NON-STERILE) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GOOD GLOVE CORP. 1110-145. LIN HAI ROAD TUNG HAI TSON, FANG LIAO Hsiang, Pingtung County, TW |
| Contact | Max Ma |
| Correspondent | Max Ma GOOD GLOVE CORP. 1110-145. LIN HAI ROAD TUNG HAI TSON, FANG LIAO Hsiang, Pingtung County, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-09-11 |