The following data is part of a premarket notification filed by Medtech Intl., Inc. with the FDA for Cut Resistant Gloves Or Surgical Glove Liner.
| Device ID | K920876 |
| 510k Number | K920876 |
| Device Name: | CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER |
| Classification | Surgeon's Gloves |
| Applicant | MEDTECH INTL., INC. 455 DOUGLASS AVE. SUITE 2155-30 Altamonte Springs, FL 32714 |
| Contact | Brian Lemay |
| Correspondent | Brian Lemay MEDTECH INTL., INC. 455 DOUGLASS AVE. SUITE 2155-30 Altamonte Springs, FL 32714 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-26 |
| Decision Date | 1992-12-11 |