The following data is part of a premarket notification filed by Interpro Intl., Inc. with the FDA for Latex Examination Gloves (mfg. Ningbo Medical).
| Device ID | K890891 |
| 510k Number | K890891 |
| Device Name: | LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) |
| Classification | Latex Patient Examination Glove |
| Applicant | INTERPRO INTL., INC. 10-26 COUNTY LINE RD. Somerville, NJ 08876 -3479 |
| Contact | Wayne Knupp |
| Correspondent | Wayne Knupp INTERPRO INTL., INC. 10-26 COUNTY LINE RD. Somerville, NJ 08876 -3479 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-22 |
| Decision Date | 1989-07-14 |