The following data is part of a premarket notification filed by Jann Maw (u.s.a.), Inc. with the FDA for J.m. Patient Examination Gloves.
| Device ID | K891624 |
| 510k Number | K891624 |
| Device Name: | J.M. PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | JANN MAW (U.S.A.), INC. 500 EAST ARAPAHO SUITE 208 Richardson, TX 75081 |
| Contact | Hartoko Sarwono |
| Correspondent | Hartoko Sarwono JANN MAW (U.S.A.), INC. 500 EAST ARAPAHO SUITE 208 Richardson, TX 75081 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1990-01-22 |