The following data is part of a premarket notification filed by Good Glove Corp. with the FDA for Powder-free Vinyl Gloves.
| Device ID | K900149 |
| 510k Number | K900149 |
| Device Name: | POWDER-FREE VINYL GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GOOD GLOVE CORP. P.O. BOX 5-119 KAOHSIUNG, TAIWAN R.O.C., TW |
| Contact | MAX MA |
| Correspondent | MAX MA GOOD GLOVE CORP. P.O. BOX 5-119 KAOHSIUNG, TAIWAN R.O.C., TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-11 |
| Decision Date | 1990-03-09 |