The following data is part of a premarket notification filed by Pm Gloves, Inc. with the FDA for Pm Glove.
| Device ID | K905055 |
| 510k Number | K905055 |
| Device Name: | PM GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | PM GLOVES, INC. 14145 PROCTOR AVE. SUITE #21 City Of Industry, CA 91746 |
| Contact | Andy K Lin |
| Correspondent | Andy K Lin PM GLOVES, INC. 14145 PROCTOR AVE. SUITE #21 City Of Industry, CA 91746 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-01-18 |